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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
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS315
Date Received08/21/2020
Decision Date11/03/2020
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.
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