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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.
 
DeviceINTERSTIM INS
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS099
Date Received11/22/2010
Decision Date12/22/2010
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
UPDATE OF AN INSPECTION PROCEDURE AND ACCEPTANCE OF RECEIVING FACILITIES FOR THE INNER AND OUTER MOLDED SEALING RING COMPONENTS.
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