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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 FOR URINARY CONTROL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS008
Date Received02/29/2000
Decision Date03/09/2000
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1)elimination of the OR screening cable from the Model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "PTFE," and 3) to make numerous minor revisions to the Physician and Hospital Staff Manual for the Model 3012 Quadripolar Neurostimulator, Models 3080 and 3886 Leads, and Model 3095 Extension.
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