[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54154-54155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22085]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-M-0244, FDA-2010-M-0220, FDA-2010-M-0219, FDA-
2010-M-0242, FDA-2010-M-0261, FDA-2010-M-0262, FDA-2010-M-0264, FDA-
2010-M-0294, FDA-2010-M-0285]
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 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:
[[Page 54155]]
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 http://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, 2010, through June 30, 2010.
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, 2010,
through June 30, 2010
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PMA No. Docket No. Applicant TRADE NAME Approval Date
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P090018 Envoy Medical Corp. ESTEEM TOTALLY IMPLANTABLE HEARING March 17, 2010
FDA-2010-M-0244 SYSTEM
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P080029 Interventional QUICK CLOSE VASCULAR SUTURING SYSTEM April 8, 2010
FDA-2010-M-0220 Therapies, LLC
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P090022 Lenstec, Inc. SOFTEC HD POSTERIOR CHAMBER April 12, 2010
FDA-2010-M-0219 INTRAOCULAR LENS (PCIOL)
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P080032 Asthmatix, Inc. ALAIR BRONCHIAL THERMOPLASTY April 27, 2010
FDA-2010-0242
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P090007 Roche Diagnostics ELECSYS ANTI-HCV IMMUNOASSAY AND April 29, 2010
FDA-2010-M-0261 Corp. ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE COBAS E411 IMMUNOASSAY
ANALYZER
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P090008 Roche Diagnostics ELECSYS ANTI-HCV IMMUNOASSAY AND April 29, 2010
FDA-2010-M-0262 Corp. ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE COBAS E601 IMMUNOASSAY
ANALYZER
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P090009 Roche Diagnostics ELECSYS ANTI-HCV IMMUNOASSAY AND April 29, 2010
FDA-2010-M-0264 Corp. ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE MODULAR ANALYTICS E170
ANALYZER
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P050027 Karl Storz PHOTODYNAMIC DIAGNOSTIC D-LIGHT C May 28, 2010
FDA-2010-M-0294 endoscopy--America,
Inc.
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P060029 Ethicon, Inc. OMNEX SURGICAL SEALANT June 3, 2010
FDA-2010-M-0285
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22085 Filed 9-2-10; 8:45 am]
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