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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestent,urethral,external sphincter,permanent
Generic Namestent,urethral,external sphincter,permanent
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP920023
Supplement NumberS007
Date Received10/01/1998
Decision Date03/29/1999
Product Code
Docket Number 99M-0870
Notice Date 04/15/1999
Advisory Committee Gastroenterology/Urology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling