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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 SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS032
Date Received05/12/2005
Decision Date05/27/2005
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A PRECAUTION STATEMENT TO THE TECHNICAL MANUAL OF THE MODEL 8840 N'VISION PROGRAMMER REGARDING THE PRESENCE OF FLAMMABLE ANESTHETIC AGENTS.
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