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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 II, MODEL 3058 NEUROSTIMULATOR
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS108
Date Received03/14/2011
Decision Date08/19/2011
Product Code EZW 
Advisory Committee Gastroenterology
Supplement Type135 Review Track For 30-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  
APPROVAL FOR CHANGES TO THE PROCEDURE FOR CONFIRMING THAT THE ULTRASONIC STAKING OF TWO WASHERS HAS BEEN PERFORMED AND A MODIFICATION OF A TOOL USED TO ENSURE THE SETSCREW IS PRESENT IN THE SETSCREW BLOCK.
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