Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 53019-53021 [05-17602]

Download as PDF Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: August 12, 2005. Carolyn M. Clancy, Director. [FR Doc. 05–17617 Filed 9–2–05; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004P–0379] Determination That Penthrane (Methoxyflurane) Inhalation Liquid, 99.9 Percent, Was Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for methoxyflurane inhalation liquid, 99.9 percent. FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new VerDate Aug<18>2005 13:21 Sep 02, 2005 Jkt 205001 drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was the subject of NDA 13–056, held by Abbott Laboratories (Abbott). Penthrane is a potent inhalation anesthetic indicated to provide anesthesia for surgical procedures in which total duration of administration is anticipated to be 4 hours or less (not to be used at concentrations that provide skeletal muscle relaxation). Penthrane was also indicated to provide analgesia in obstetrics and in minor surgical procedures and for use by selfadministration using hand held inhalers. In the Federal Register of August 16, 2001 (66 FR 43017), FDA withdrew approval of NDA 13–056 for Penthrane after Abbott notified the agency that Penthrane was no longer being marketed under NDA 13–056 and requested withdrawal of that application. Penthrane was then moved to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. In a citizen petition dated August 25, 2004 (Docket No. 2004P–0379/CP1), submitted under § 10.30 (21 CFR 10.30), and in accordance with § 314.161, AAC Consulting Group requested that the agency determine whether Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Penthrane (methoxyflurane) PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 53019 Inhalation Liquid, 99.9 percent, including the NDA file for this drug product. We have also independently evaluated relevant literature and data for possible postmarketing adverse event reports. FDA has determined under §§ 314.161 and 314.162(a)(2) that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety. FDA’s review shows that methoxyflurane, a volatile anesthetic agent, is associated with serious, irreversible, and even fatal nephrotoxicity and hepatotoxicity in humans. FDA has also reviewed the latest approved labeling for Penthrane and has determined that this labeling is inadequate. FDA believes that the risks of toxicity outweigh any potential benefits if methoxyflurane is used according to the latest approved labeling. Since the initial approval of Penthrane in 1962, with a subsequent finding of efficacy in the Federal Register of December 11, 1981 (46 FR 60652), alternative safe and effective anesthetics have been approved by FDA and entered the market. FDA has determined that new clinical studies are necessary before methoxyflurane could be considered for reintroduction to the market. The agency has determined, under § 314.161, that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent was withdrawn from sale for reasons of safety. Therefore, Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, will be removed from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. Dated: August 29, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–17559 Filed 9–2–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2005M–0158, 2005M–0159, 2005M–0129, 2005M–0160, 2005M–0130, 2005M–0151, 2005M–0117, 2005M–0118, 2005M–0241, 2005M–0191, 2005M–0192, 2005M–0193, 2005M–0270] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a E:\FR\FM\06SEN1.SGM 06SEN1 53020 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2186. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2005, through June 30, 2005. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 2005, THROUGH JUNE 30, 2005. PMA No./Docket No. Applicant TRADE NAME P030040/2005M–0158 Bayer Healthcare, LLC ADVIA CENTAUR HBC IGM READY PACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIAL August 6, 2004 P020055/2005M–0159 Ventana Medical Systems, Inc. VENTANA MEDICAL SYSTEMS PATHWAY ANTI–C–KIT (9.7) PRIMARY ANTIBODY August 11, 2004 P040018/2005M–0129 Bayer Healthcare, LLC ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIAL December 22, 2004 P040030/2005M–0160 BioGenex Laboratories, Inc. INSITE HER–2/NEU KIT December 22, 2004 P030052/2005M–0130 Vysis, Inc. UROVYSION BLADDER CANCER KIT January 24, 2005 P930016(S20)/2005M– 0151 VISX, Inc. STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) March 17, 2005 P040020/2005M–0117 Alcon Research, Ltd. ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL March 21, 2005 P040024/2005M–0118 Medicis Aesthetics Holdings, Inc. RESTYLANE INJECTABLE GEL March 25, 2005 P040026/2005M–0241 Medispec, Ltd. ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE April 1, 2005 P040034/2005M–0191 Confluent Surgical, Inc. DURASEAL DURAL SEALANT SYSTEM April 7, 2005 P040016/2005M–0192 Boston Scientific Corp. BOSTON SCIENTIFIC CORPORATION LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS April 12, 2005 P030037/2005M–0193 Biotronik, Inc. RITHRON–XR CORONARY STENT SYSTEM April 29, 2005 P030049/2005M–0270 Bayer Healthcare, LLC ADVIA CENTAUR HBS AG READY PACK REAGENTS, ADVIA CENTAUR HBS AG CONFIRMATORY READY PACK REAGENTS, AND ADVIA CENTAUR HBS AG QUALITY CONTROL MATERIAL May 31, 2005 VerDate Aug<18>2005 13:21 Sep 02, 2005 Jkt 205001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM Approval Date 06SEN1 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: August 22, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–17602 Filed 9–2–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0324] International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘M5 Data Elements and Standards for Drug Dictionaries.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the data elements and standards that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance is intended to facilitate the exchange and practical use of medicinal product information at the international level, such as with postmarketing safety reporting. DATES: Submit written or electronic comments on the draft guidance by October 21, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training, and VerDate Aug<18>2005 13:21 Sep 02, 2005 Jkt 205001 Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling the CBER Voice Information System at 1–800–835–4709 or 301–827– 1800. Send two self-addressed adhesive labels to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Randy Levin, Center for Drug Evaluation and Research (HFD–001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301– 827–7784; or Ann Schwartz, Center for Biologics Evaluation and Research (HFM–475), Food and Drug Administration, 1401 Rockville Pike, rm. 300N, Rockville, MD 20832, 301–827–3070. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 53021 Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of ICH’s sponsors and IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In May 2005, the ICH Steering Committee agreed that a draft guidance entitled ‘‘M5 Data Elements and Standards for Drug Dictionaries’’ should be made available for public comment. The draft guidance is the product of the M5 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the M5 expert working group. The draft guidance describes the data elements that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance outlines each data element and provides recommended standards for the data elements. The draft guidance addresses medicinal products (drugs and biologics) and is intended to accomplish the following goals: • Improve the exchange of medicinal product information, • Improve consistency in evaluating and comparing medicinal products for postmarketing surveillance activities, • Provide consistent terminology for the health care community, and • Reduce administrative burdens for the pharmaceutical industry when complying with different regional regulatory requirements. The draft guidance refers to approved medicinal products. The draft guidance does not apply to homeopathic medicinal products or investigational medicinal products. The draft guidance does not cover the establishment and maintenance of a drug dictionary. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on M5 data elements and standards for drug dictionaries. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Notices]
[Pages 53019-53021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17602]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2005M-0158, 2005M-0159, 2005M-0129, 2005M-0160, 2005M-
0130, 2005M-0151, 2005M-0117, 2005M-0118, 2005M-0241, 2005M-0191, 
2005M-0192, 2005M-0193, 2005M-0270]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a

[[Page 53020]]

list of premarket approval applications (PMAs) that have been approved. 
This list is intended to inform the public of the availability of 
safety and effectiveness summaries of approved PMAs through the 
Internet and the agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Please cite the appropriate docket number as listed in table 1 
of this document when submitting a written request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register. Instead, the agency now posts this information on the 
Internet on FDA's home page at https://www.fda.gov. FDA believes that 
this procedure expedites public notification of these actions because 
announcements can be placed on the Internet more quickly than they can 
be published in the Federal Register, and FDA believes that the 
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the act. The 30-day 
period for requesting reconsideration of an FDA action under Sec.  
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA 
begins on the day the notice is placed on the Internet. Section 
10.33(b) provides that FDA may, for good cause, extend this 30-day 
period. Reconsideration of a denial or withdrawal of approval of a PMA 
may be sought only by the applicant; in these cases, the 30-day period 
will begin when the applicant is notified by FDA in writing of its 
decision.
    The regulations provide that FDA publish a quarterly list of 
available safety and effectiveness summaries of PMA approvals and 
denials that were announced during that quarter. The following is a 
list of approved PMAs for which summaries of safety and effectiveness 
were placed on the Internet from April 1, 2005, through June 30, 2005. 
There were no denial actions during this period. The list provides the 
manufacturer's name, the product's generic name or the trade name, and 
the approval date.

    Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2005,
                                             through June 30, 2005.
----------------------------------------------------------------------------------------------------------------
   PMA No./Docket No.          Applicant                        TRADE NAME                      Approval Date
----------------------------------------------------------------------------------------------------------------
P030040/2005M-0158       Bayer Healthcare, LLC  ADVIA CENTAUR HBC IGM READY PACK REAGENTS,  August 6, 2004
                                                ADVIA CENTAUR HBC IGM QUALITY CONTROL
                                                 MATERIAL
----------------------------------------------------------------------------------------------------------------
P020055/2005M-0159       Ventana Medical        VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT  August 11, 2004
                          Systems, Inc.          (9.7)
                                                PRIMARY ANTIBODY
----------------------------------------------------------------------------------------------------------------
P040018/2005M-0129       Bayer Healthcare, LLC  ADVIA CENTAUR HAV IGM READY PACK REAGENTS,  December 22, 2004
                                                ADVIA CENTAUR HAV IGM QUALITY CONTROL
                                                 MATERIAL
----------------------------------------------------------------------------------------------------------------
P040030/2005M-0160       BioGenex               INSITE HER-2/NEU KIT                        December 22, 2004
                          Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
P030052/2005M-0130       Vysis, Inc.            UROVYSION BLADDER CANCER KIT                January 24, 2005
----------------------------------------------------------------------------------------------------------------
P930016(S20)/2005M-0151  VISX, Inc.             STAR S4 IR EXCIMER LASER SYSTEM WITH        March 17, 2005
                                                 VARIABLE
                                                SPOT SCANNING (VSS)
----------------------------------------------------------------------------------------------------------------
P040020/2005M-0117       Alcon Research, Ltd.   ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC   March 21, 2005
                                                POSTERIOR CHAMBER IOL
----------------------------------------------------------------------------------------------------------------
P040024/2005M-0118       Medicis Aesthetics     RESTYLANE INJECTABLE GEL                    March 25, 2005
                          Holdings, Inc.
----------------------------------------------------------------------------------------------------------------
P040026/2005M-0241       Medispec, Ltd.         ORTHOSPEC EXTRACORPOREAL SHOCK WAVE         April 1, 2005
                                                 THERAPY DEVICE
----------------------------------------------------------------------------------------------------------------
P040034/2005M-0191       Confluent Surgical,    DURASEAL DURAL SEALANT SYSTEM               April 7, 2005
                          Inc.
----------------------------------------------------------------------------------------------------------------
P040016/2005M-0192       Boston Scientific      BOSTON SCIENTIFIC CORPORATION LIBERTE       April 12, 2005
                          Corp.                  MONORAIL
                                                AND OVER-THE-WIRE CORONARY STENT SYSTEMS
----------------------------------------------------------------------------------------------------------------
P030037/2005M-0193       Biotronik, Inc.        RITHRON-XR CORONARY STENT SYSTEM            April 29, 2005
----------------------------------------------------------------------------------------------------------------
P030049/2005M-0270       Bayer Healthcare, LLC  ADVIA CENTAUR HBS AG READY PACK REAGENTS,   May 31, 2005
                                                 ADVIA CENTAUR HBS AG CONFIRMATORY READY
                                                 PACK REAGENTS, AND ADVIA CENTAUR HBS AG
                                                 QUALITY CONTROL MATERIAL
----------------------------------------------------------------------------------------------------------------


[[Page 53021]]

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
https://www.fda.gov/cdrh/pmapage.html.

    Dated: August 22, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-17602 Filed 9-2-05; 8:45 am]
BILLING CODE 4160-01-S

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