Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 14053-14054 [2014-05347]

Download as PDF Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices Food and Drug Administration [Docket Nos. FDA–2013–M–1321, FDA– 2013–M–1322, FDA–2013–M–1323, FDA– 2013–M–1362, FDA–2013–M–1363, FDA– 2013–M–1364, FDA–2013–M–1365, FDA– 2013–M–1488, and FDA–2013–M–1605] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a 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. SUMMARY: Submit written requests for copies of summaries of safety and effectiveness data 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 when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993–0002, 301–796–6570. SUPPLEMENTARY INFORMATION: ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 14053 order under section 515(g) of the FD&C 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 October 1, 2013, through December 31, 2013. 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 OCTOBER 1, 2013, THROUGH DECEMBER 31, 2013 PMA No., Docket No. Applicant Trade Name Approval Date P040043/S051, FDA–2013–M–1323 ..... P970053/S011, FDA–2013–M–1362 ..... P020050/S012, FDA–2013–M–1321 ..... W.L. Gore & Associates, Inc ....... Nidek Co., Ltd ............................. Alcon Research, Ltd .................... September 10, 2013. September 30, 2013. October 2, 2013. H120005, FDA–2013–M–1322 ............... P130005, FDA–2013–M–1363 ............... Kaneka Pharma America LLC .... Cardiovascular Systems, Inc ...... P110033, FDA–2013–M–1364 ............... P100009, FDA–2013–M–1365 ............... Allergan ....................................... Abbott Vascular ........................... P100026, FDA–2013–M–1488 ............... P130006, FDA–2013–M–1605 ............... NeuroPace, Inc ........................... W.L. Gore & Associates, Inc ....... GORE® TAG® Thoracic Endoprosthesis Nidek EC–5000 Excimer Laser System ... ALLEGRETTO WAVE® Eye-Q Excimer Laser System. Kaneka Liposorber® LA–15 System ......... Diamondback 360® Coronary Orbital Arthrectomy System. ´ JUVEDERM® VOLUMATM XC ................. MitraClip Clip Delivery System (MitraClip CDS). RNS® System ........................................... GORE® VIABAHN® Endoprosthesis & GORE® VIABAHB® Endoprosthesis with Heparin BioActive Surface. II. Electronic Access tkelley on DSK3SPTVN1PROD with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Dated: March 7, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–05429 Filed 3–11–14; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–M–0851, FDA– 2013–M–0987, FDA–2013–M–0988, FDA– 2013–M–1017, FDA–2013–M–1095, FDA– 2013–M–1159, and FDA–2013–M–1206] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: BILLING CODE 4160–01–P Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a SUMMARY: VerDate Mar<15>2010 17:51 Mar 11, 2014 Jkt 232001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 October 10, 2013. October 21, 2013. October 22, 2013. October 24, 2013. November 14, 2013. December 5, 2013. 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 data 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 when submitting a written request. See the SUPPLEMENTARY INFORMATION section for ADDRESSES: E:\FR\FM\12MRN1.SGM 12MRN1 14054 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–6570. SUPPLEMENTARY INFORMATION: I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 July 1, 2013, through September 30, 2013. 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 JULY 1, 2013, THROUGH SEPTEMBER 30, 2013 PMA No., Docket No. Applicant Trade name Approval date .............. .............. .............. .............. .............. .............. QIAGEN Manchester Ltd .............. LDR Spine USA, Inc ..................... PFM Medical AG ........................... Parascript, LLC ............................. LDR Spine USA, Inc ..................... Medtronic Vascular ....................... July 12, 2013. August 7, 2013. August 16, 2013. August 22, 2013. August 23, 2013. September 19, 2013. P120010, FDA–2013–M–1206 .............. Medtronic, Inc ............................... therascreen® EGFR RGQ PCR Kit ......... Mobi-C® Cervical Disc Prosthesis ........... Nit-Occlud® PDA ...................................... Parascript® AccuDetect® 6.1.0 ................ Mobi-C® Cervical Disc Prosthesis ........... Medtronic Vascular Complete® SE Vascular Stent System. MiniMed 530G System ............................. P120022, P110002, P120009, P120004, P110009, P110040, FDA–2013–M–0851 FDA–2013–M–0987 FDA–2013–M–0988 FDA–2013–M–1017 FDA–2013–M–1095 FDA–2013–M–1159 II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Dated: March 6, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–05347 Filed 3–11–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0253] Methods for Thrombogenicity Testing; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. tkelley on DSK3SPTVN1PROD with NOTICES ACTION: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Workshop on Methods for Thrombogenicity Testing.’’ Planned topics of discussion include the optimization of in vitro and in vivo thrombogenicity test methods and the VerDate Mar<15>2010 17:51 Mar 11, 2014 Jkt 232001 identification of alternative in vitro tests. Date and Time: The public workshop will be held on April 14, 2014, from 9 a.m. to 5 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503, sections B and C), Silver Spring, MD 20993–0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Contact Persons: Anchal Kaushiva, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1266, Silver Spring, MD 20993– 0002, 301–796–6330, FAX: 301–847– 8115, email: anchal.kaushiva@ fda.hhs.gov, or James Kleinedler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1102, Silver Spring, MD 20993–0002, 301–796–9448, FAX: 301–847–8115, email: james.kleinedler@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 September 26, 2013. this public workshop must register online by April 4, 2014, at 5 p.m., EST. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the workshop will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, 301–796–5661, email: susan.monahan@fda.hhs.gov no later than April 4, 2014. To register for the public workshop, please visit FDA’s Medical Devices News & Events—Workshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm and select this public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, and affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by April 4, 2014, at 5 p.m. Early registration is recommended because E:\FR\FM\12MRN1.SGM 12MRN1

Agencies

[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14053-14054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05347]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-M-0851, FDA-2013-M-0987, FDA-2013-M-0988, FDA-
2013-M-1017, FDA-2013-M-1095, FDA-2013-M-1159, and FDA-2013-M-1206]

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 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 data 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 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for

[[Page 14054]]

electronic access to the summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 July 1, 2013, through September 30,
2013. 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 July 1, 2013, Through
September 30, 2013
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P120022, FDA-2013-M-0851....................... QIAGEN therascreen[supr July 12, 2013.
Manchester Ltd. eg] EGFR RGQ
PCR Kit.
P110002, FDA-2013-M-0987....................... LDR Spine USA, Mobi-C[supreg] August 7, 2013.
Inc. Cervical Disc
Prosthesis.
P120009, FDA-2013-M-0988....................... PFM Medical AG.. Nit- August 16, 2013.
Occlud[supreg]
PDA.
P120004, FDA-2013-M-1017....................... Parascript, LLC. Parascript[supre August 22, 2013.
g]
AccuDetect[supr
eg] 6.1.0.
P110009, FDA-2013-M-1095....................... LDR Spine USA, Mobi-C[supreg] August 23, 2013.
Inc. Cervical Disc
Prosthesis.
P110040, FDA-2013-M-1159....................... Medtronic Medtronic September 19, 2013.
Vascular. Vascular
Complete[supreg
] SE Vascular
Stent System.
P120010, FDA-2013-M-1206....................... Medtronic, Inc.. MiniMed 530G September 26, 2013.
System.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

Dated: March 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05347 Filed 3-11-14; 8:45 am]
BILLING CODE 4160-01-P

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