|
Device | MODEL 3058 INTERSTIM II NEUROSTIMULATOR |
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 | S022 |
Date Received | 10/12/2011 |
Decision Date | 02/10/2012 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN AND SPECIFICATION CHANGES TO THE MODEL 3058 INTERSTIM II BATTERY. |