[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50422-50423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20085]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-M-0462, FDA-2013-M-0463, FDA-2013-M-0464, FDA-
2013-M-0549, FDA-2013-M-0592, FDA-2013-M-0594, FDA-2013-M-0595, FDA-
2013-M-0709, FDA-2013-M-0724, FDA-2013-M-0738, and FDA-2013-M-0758]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
[[Page 50423]]
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 April 1, 2013, through June 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 April 1, 2013, Through
June 30, 2013
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PMA No., Docket No. Applicant Trade name Approval date
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P120016, FDA-2013-M-0592..... Cardiva Medical, Inc. VASCADE Vascular Closure January 31, 2013.
System (VCS).
P070026/S004, FDA-2013-M-0462 DePuy Orthopaedics, DuPuy Ceramax Ceramic Total April 2, 2013.
Inc.. Hip System.
P960043/S080, FDA-2013-M-0464 Abbott Vascular...... PERCLOSE PROGLIDE Suture April 15, 2013.
Mediated Closure System.
P980040/S039, FDA-2013-M-0463 Abbott Medical TECNIS Toric 1-Piece April 15, 2013.
Optics, Inc.. Intraocular Lens (IOL) and
the TECNIS Toric Calculator
System.
P080009, FDA-2013-M-0549..... Ethicon Endo-Surgery, SEDASYS Computer-Assisted May 3, 2013.
Inc.. Personalized Sedation System.
P120019, FDA-2013-M-0594..... Roche Molecular COBAS EGFR Mutation Test...... May 14, 2013.
Systems, Inc..
P080003/S001, FDA-2013-M-0595 Hologic, Inc......... Selenia Dimensions 3D System.. May 16, 2013.
P030002/S027, FDA-2013-M-0724 Bausch+Lomb, Inc..... TRULIGN Toric Posterior May 20, 2013.
Chamber Intraocular Lens.
P120014, FDA-2013-M-0709..... bioM[eacute]rieux, THxID BRAF Kit for use on the May 29, 2013.
Inc.. ABI 7500 Fast DX Real-Time
PCR Instrument.
P060028, FDA-2013-M-0738..... Mentor Worldwide LLC. MEMORYSHAPE Breast Implants... June 14, 2013.
P120012, FDA-2013-M-0758..... Abbott Molecular, Abbott RealTime HCV Genotype June 20, 2013.
Inc.. II, Abbott RealTime HCV
Genotype II Control Kit, and
Uracil-N-Glycosylase (UNG).
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20085 Filed 8-16-13; 8:45 am]
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