|
Device | InterStim Therapy System and Verify Evaluation System (SNS Bowel Neurostimulators Implantable InterStim) |
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 | S168 |
Date Received | 05/16/2018 |
Decision Date | 06/15/2018 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes in component material, associated equipment, process sequence, and supplier of Ethylene tetrafluoroethylene used for insulating battery headers of the impacted devices. |