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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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Information about this document as published in the Federal Register.

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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.

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Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186.

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I. Background

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;​ 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.

Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available July 1, 2001, through September 30, 2001

PMA No./Docket No.ApplicantTrade NameApproval Date
P970056/01M-0309Bausch & Lomb SurgicalKERACOR 116 Ophthalmic Excimer Laser SystemSeptember 28, 1999
P980044/01M-0342Quintiles, Inc.SUPARTZ DispoJanuary 24, 2001
P000016/01M-0329GE Medical Systems Information TechnologiesCorometrics Model 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring, Corometrics Fetal Patient Module, and the Nellcor OXIFIRST FS14 SensorFebruary 9, 2001
P000007/01M-0381Edwards Lifesciences, LLCEDWARDS PRIMA Plus Bioprosthesis Model 2500PFebruary 27, 2001
P990026/01M-0371Cygnus, Inc.GLUCOWATCH Automatic Glucose BiographerMarch 22, 2001
P000032/01M-0412CryoGen, Inc.HEROPTION UTERINE CRYOBLATION THERAPY SystemApril 20, 2001
P930016(S12)/01M-0305VISX, Inc.STAR Excimer Laser System Models S2 and S3April 27, 2001
P000005/01M-0337MediTeam ABCARISOLV Non-Invasive Dental Caries Removal SystemJune 27, 2001
P000043/01M-0296TherMatrx, Inc.TMx2000 BPH Thermotherapy SystemJune 29, 2001
P000021/01M-0310Dade Behring, Inc.DIMENSION RxL PSA Reagent CartridgeJuly 5, 2001
P000041/01M-0306Deus Technologies, LLCRAPIDSCREEN RS-2000July 12, 2001
P000026/01M-0307STAAR Surgical Co.AQUAFLOW Collegen Glaucoma Drainage Device, Model CGDD-20July 12, 2001
P000055/01M-0360Diagnostic Medical SystemsUBIS 5000July 17, 2001
P830039(S7)/01M-0380Medical CV, Inc.OMNICARBON Cardiac Valve ProsthesisJuly 26, 2001
P010015/01M-0373Medtronic, Inc.INSYNC Biventricular Pacing System including INSYNC Model 8040 Pulse Generator, ATTAIN LV Model 2187 and ATTAIN CS Model 2188 LeadsAugust 28, 2001
H010001/01M-0392Avanta Orthopaedics, Inc.Avanta Metacarpophalangeal (MCP) Joint Implant Finger ProsthesisAugust 28, 2001
P010016/01M-0413Ortec International, Inc.ORCEL (Bilayered Cellular Matrix)August 31, 2001
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P010023/01M-0414SOUNDTEC, Inc.SOUNDTEC Direct SystemSeptember 7, 2001
P000029/01M-0439Q-Med ABDEFLUX Injectable GelSeptember 24, 2001

II. Electronic Access

Persons with access to the Internet may obtain the documents at​cdrh/​pmapage.html.

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Dated: December 31, 2001.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 02-853 Filed 1-11-02; 8:45 am]