Food and Drug Administration, HHS.
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.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule to revise §§ 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 §§ 814.44(d) and 814.45(d) state that FDA will notify the public of PMA approvals and denials by posting them 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 § 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 from July 1, 2001, through September 30, 2001, in accordance with the procedure explained previously. 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.
|PMA No./Docket No.||Applicant||Trade Name||Approval Date|
|P970056/01M-0309||Bausch & Lomb Surgical||KERACOR 116 Ophthalmic Excimer Laser System||September 28, 1999|
|P980044/01M-0342||Quintiles, Inc.||SUPARTZ Dispo||January 24, 2001|
|P000016/01M-0329||GE Medical Systems Information Technologies||Corometrics Model 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring, Corometrics Fetal Patient Module, and the Nellcor OXIFIRST FS14 Sensor||February 9, 2001|
|P000007/01M-0381||Edwards Lifesciences, LLC||EDWARDS PRIMA Plus Bioprosthesis Model 2500P||February 27, 2001|
|P990026/01M-0371||Cygnus, Inc.||GLUCOWATCH Automatic Glucose Biographer||March 22, 2001|
|P000032/01M-0412||CryoGen, Inc.||HEROPTION UTERINE CRYOBLATION THERAPY System||April 20, 2001|
|P930016(S12)/01M-0305||VISX, Inc.||STAR Excimer Laser System Models S2 and S3||April 27, 2001|
|P000005/01M-0337||MediTeam AB||CARISOLV Non-Invasive Dental Caries Removal System||June 27, 2001|
|P000043/01M-0296||TherMatrx, Inc.||TMx2000 BPH Thermotherapy System||June 29, 2001|
|P000021/01M-0310||Dade Behring, Inc.||DIMENSION RxL PSA Reagent Cartridge||July 5, 2001|
|P000041/01M-0306||Deus Technologies, LLC||RAPIDSCREEN RS-2000||July 12, 2001|
|P000026/01M-0307||STAAR Surgical Co.||AQUAFLOW Collegen Glaucoma Drainage Device, Model CGDD-20||July 12, 2001|
|P000055/01M-0360||Diagnostic Medical Systems||UBIS 5000||July 17, 2001|
|P830039(S7)/01M-0380||Medical CV, Inc.||OMNICARBON Cardiac Valve Prosthesis||July 26, 2001|
|P010015/01M-0373||Medtronic, Inc.||INSYNC Biventricular Pacing System including INSYNC Model 8040 Pulse Generator, ATTAIN LV Model 2187 and ATTAIN CS Model 2188 Leads||August 28, 2001|
|H010001/01M-0392||Avanta Orthopaedics, Inc.||Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis||August 28, 2001|
|P010016/01M-0413||Ortec International, Inc.||ORCEL (Bilayered Cellular Matrix)||August 31, 2001|
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|P010023/01M-0414||SOUNDTEC, Inc.||SOUNDTEC Direct System||September 7, 2001|
|P000029/01M-0439||Q-Med AB||DEFLUX Injectable Gel||September 24, 2001|
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.Start Signature
Dated: December 31, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-853 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-01-S