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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 Therapy System, Verify Evaluation System
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Ms Rcw225
Minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS210
Date Received08/21/2020
Decision Date11/03/2020
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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