Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 14053 [2014-05429]

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

Agencies

[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Page 14053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05429]

[[Page 14053]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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

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 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 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........ W.L. Gore & Associates, GORE[supreg] September 10, 2013.
Inc. TAG[supreg] Thoracic
Endoprosthesis.
P970053/S011, FDA-2013-M-1362........ Nidek Co., Ltd......... Nidek EC-5000 Excimer September 30, 2013.
Laser System.
P020050/S012, FDA-2013-M-1321........ Alcon Research, Ltd.... ALLEGRETTO WAVE[supreg] October 2, 2013.
Eye-Q Excimer Laser
System.
H120005, FDA-2013-M-1322............. Kaneka Pharma America Kaneka October 10, 2013.
LLC. Liposorber[supreg] LA-
15 System.
P130005, FDA-2013-M-1363............. Cardiovascular Systems, Diamondback 360[supreg] October 21, 2013.
Inc. Coronary Orbital
Arthrectomy System.
P110033, FDA-2013-M-1364............. Allergan............... JUV[Eacute]DERM[supreg] October 22, 2013.
VOLUMATM XC.
P100009, FDA-2013-M-1365............. Abbott Vascular........ MitraClip Clip Delivery October 24, 2013.
System (MitraClip CDS).
P100026, FDA-2013-M-1488............. NeuroPace, Inc......... RNS[supreg] System..... November 14, 2013.
P130006, FDA-2013-M-1605............. W.L. Gore & Associates, GORE[supreg] December 5, 2013.
Inc. VIABAHN[supreg]
Endoprosthesis &
GORE[supreg]
VIABAHB[supreg]
Endoprosthesis with
Heparin BioActive
Surface.
----------------------------------------------------------------------------------------------------------------

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 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05429 Filed 3-11-14; 8:45 am]
BILLING CODE 4160-01-P

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