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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, Verify Evaluation System (SNS Urinary)
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS310
Date Received04/09/2020
Decision Date05/08/2020
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  
Change requested to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.
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