[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35920-35921]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn06-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0075, 2006M-0009, 2006M-0014, 2006M-0015, 2006M-
0163]
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 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: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
SUPPLEMENTARY INFORMATION:
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 January 1, 2006, through March 31,
2006. 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, 2006, through March 31, 2006
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P020024/2006M- AGA Medical AMPLATZER DUCT May 14, 2003
0075 Corp. OCCULUDER AND
180 DELIVERY
SYSTEM
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P020001/2006M- Neoventa STAN S31 FETAL November 1, 2005
0009 Medical AB HEART MONITOR
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P040001/2006M- St. Francis X STOP November 21, 2005
0014 Medical INTERSPINOUS
Technologie PROCESS
s, Inc. DECROMPRESSIO
N SYSTEM
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P050009/2006M- Biomet, Inc. C2 A-TAPER December 16, 2005
0015 ACETABULAR
SYSTEM
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[[Page 35921]]
P050007/2006M- Abbott STARCLOSE December 21, 2005
0016 Vascular VASCULAR
Devices CLOSURE
(AVD) SYSTEM
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H040005/2006M- Karl Storz KARL STORZ March 31, 2006
0163 Endoscopy- RIGID TTTS
America, FETOSCOPY
Inc. INSTRUMENT
SET WITH 0
AND 12 DEGREE
SCOPE, KARL
STORZ RIGID
TTTS
FETOSCOPY
INSTRUMENT
SET WITH 30
DEGREE SCOPE,
AND KARL
STORZ SEMI-
RIGID TTTS
FETOSCOPY
INSTRUMENT
SET
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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: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-9898 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S