[Federal Register: July 17, 2002 (Volume 67, Number 137)]
[Notices]
[Page 46990-46991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy02-91]
[[Page 46990]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 02M-0083, 02M-0082, 02M-0006, 02M-0128, 02M-0076, 02M-
0034, 02M-0030, 02M-0060, 02M-0118, 02M-0121, and 02M-0134]
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 Dockets Management Branch.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness to the Dockets Management Branch (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.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule to revise Secs. 814.44(d) and 814.45(d) (21 CFR
814.44(d) and 814.45(d)) to discontinue publication of individual PMA
approvals and denials in the Federal Register. Instead, revised
Secs. 814.44(d) and 814.45(d) state that FDA will notify the public of
PMA approvals and denials by posting them on FDA's home page on the
Internet at http://www.fda.gov, by placing the summaries of safety and
effectiveness on the Internet and in FDA's Dockets Management Branch,
and by publishing in the Federal Register after each quarter a list of
available safety and effectiveness summaries of approved PMAs and
denials announced in that quarter.
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 following is a list of approved PMAs for which summaries of
safety and effectiveness were placed on the Internet in accordance with
the procedure explained previously from January 1, 2002, through March
31, 2002. 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 January 1, 2002, through March 31, 2002
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PMA Number/Docket
No. Applicant Trade Name Approval Date
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P000012/02M-0083 Roche Molecular COBAS AMPLICOR July 3, 2001.
Systems, Inc. Hepatitis C
Virus Test,
version 2.0.
P000010/02M-0082 Roche Molecular AMPLICOR July 5, 2001.
Systems, Inc. Hepatitis C
Virus Test,
version 2.0.
P000025/02M-0006 Med-El Corp. MED-EL COMBI 40+ August 20, 2001.
Cochlear
Implant System.
P010013/02M-0128 Novacept, Inc. NOVASURE September 28,
Impedance 2001.
Controlled
Endometrial
Ablation
System.
P010022/02M-0076 Cohesion COSEAL Surgical December 14,
Technologies, Sealant. 2001.
Inc.
P000048/02M-0034 Dornier Medical DORNIER EPOS January 15,
Systems, Inc. ULTRA. 2002.
P010038/02M-0030 Intelligent MAMMOREADER January 15,
Systems (Computer-Aided 2002.
Software, Inc. Detection
System For
Mammography).
P010034/02M-0060 CADx Medical SECOND LOOK January 31,
Systems, Inc. (Computer-Aided 2002.
Detection
System For
Mammography).
P010040/02M-0118 Safeguard Medical The March 15, 2002.
Devices, Inc. DISINTEGRATOR
Insulin Needle
Destruction
Device.
H010005/02M-0121 Ascension ASCENSION PIP. March 22, 2002.
Orthopedics,
Inc.
P010049/02M-0134 SUB-Q, Inc. QuickSeal March 25, 2002.
Femoral
Arterial
Closure System.
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[[Page 46991]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: July 5, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-18038 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S