|
Device | InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads |
Generic Name | Implanted electrical device intended for treatment of fecal incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MS RCW225 MINNEAPOLIS, MN 55432 |
PMA Number | P080025 |
Supplement Number | S263 |
Date Received | 06/28/2022 |
Decision Date | 09/23/2022 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to update the pinch flash requirement on a distal section of the lead body assemblies and loosening the outer diameter (OD) tolerance on a proximal section of the lead body assemblies. |