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U.S. Department of Health and Human Services

Devices@FDA
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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 THERAPY SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS207
Date Received10/29/2015
Decision Date11/20/2015
Product Code EZW 
Advisory Committee Gastroenterology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
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