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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS004
Date Received10/21/1998
Decision Date04/15/1999
Product Code
EZW[ Registered Establishments with EZW ]
Docket Number 99M-1306
Notice Date 07/12/1999
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 Statement 
Approval for the Medtronic(R) Interstim(R) System for Urinary Control. This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling