Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 35284 [2013-13905]

Download as PDF 35284 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section 320.31(d) Bioavailability and Bioequivalence Safety Reports .................................................................................. 312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 312.32(c)(1)(iv) IND Safety Reports .................................... Number of responses per respondent 10 100 10 Total annual responses 20 6 1 Average burden per response 200 600 10 Total hours 14 12 12 2,800 7,200 120 Total .............................................................................. 1 There Dated: June 7, 2013. Leslie Kux, Assistant Commissioner for Policy. 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 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. ADDRESSES: [FR Doc. 2013–13904 Filed 6–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–M–0036, FDA– 2013–M–0205, FDA–2013–M–0255, FDA– 2013–M–0281, FDA–2013–M–0282, and FDA–2013–M–0343] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: 10,120 are no capital costs or operating and maintenance costs associated with this collection of information. 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 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 January 1, 2013, through March 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 JANUARY 1, 2013, THROUGH MARCH 31, 2013 Applicant Trade name Approval date P110014, FDA–2013–M–0036 .............. Dune Medical Devices, Inc .................. MarginProbe System ............................ H110002, FDA–2013–M–0205 .............. P110032, FDA–2013–M–0282 .............. P040046, FDA–2013–M–0255 .............. Second Sight Medical Products, Inc .... Lombard Medical .................................. Allergan ................................................ Medtronic Vascular, Inc ....................... P100030, FDA–2013–M–0281 .............. Tenaxis Medical, Inc ............................ ArgusTM II Retinal Prosthesis System Aorfix AAA Flexible Stent Graft System Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants. Resolute Integrity Zotarolimus-Eluting Coronary Stent System. ArterX Surgical Sealant ........................ December 27, 2012. February 13, 2013. February 14, 2013. February 20, 2013. P110013/S005, FDA–2013–M–0343 ..... mstockstill on DSK4VPTVN1PROD with NOTICES PMA No., docket No. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ VerDate Mar<15>2010 16:32 Jun 11, 2013 Jkt 229001 DeviceApprovalsandClearances/ PMAApprovals/default.htm. February 22, 2013. March 1, 2013. Dated: June 7, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–13905 Filed 6–11–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00046 Fmt 4703 Sfmt 9990 E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Page 35284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13905]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-M-0036, FDA-2013-M-0205, FDA-2013-M-0255, FDA-
2013-M-0281, FDA-2013-M-0282, and FDA-2013-M-0343]

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 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: 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 January 1, 2013, through March 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 January 1, 2013,
Through March 31, 2013
----------------------------------------------------------------------------------------------------------------
PMA No., docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P110014, FDA-2013-M-0036.......... Dune Medical Devices, MarginProbe System... December 27, 2012.
Inc.
H110002, FDA-2013-M-0205.......... Second Sight Medical ArgusTM II Retinal February 13, 2013.
Products, Inc. Prosthesis System.
P110032, FDA-2013-M-0282.......... Lombard Medical...... Aorfix AAA Flexible February 14, 2013.
Stent Graft System.
P040046, FDA-2013-M-0255.......... Allergan............. Natrelle[supreg] 410 February 20, 2013.
Highly Cohesive
Anatomically Shaped
Silicone-Filled
Breast Implants.
P110013/S005, FDA-2013-M-0343..... Medtronic Vascular, Resolute Integrity February 22, 2013.
Inc. Zotarolimus-Eluting
Coronary Stent
System.
P100030, FDA-2013-M-0281.......... Tenaxis Medical, Inc. ArterX Surgical March 1, 2013.
Sealant.
----------------------------------------------------------------------------------------------------------------

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: June 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13905 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.