THE ARTIFICIAL URINARY SPHINCTER

Prosthesis, Urethral Sphincter

AMERICAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for The Artificial Urinary Sphincter.

Pre-market Notification Details

Device IDK821627
510k NumberK821627
Device Name:THE ARTIFICIAL URINARY SPHINCTER
ClassificationProsthesis, Urethral Sphincter
Applicant AMERICAN MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFAG  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-02
Decision Date1982-08-10

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