|
Device | InterStim Therapy System, Verify Evaluation System |
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 | S195 |
Date Received | 09/12/2019 |
Decision Date | 10/10/2019 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the Verify External Neurostimulator User Manual by 1) adding a warning regarding making connections outside the sterile field; and 2) adding a caution regarding battery depletion and replacement. |