|
Device | INTERSTIM THERAPY FOR BOWEL CONTROL |
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 | S049 |
Date Received | 03/07/2013 |
Decision Date | 04/15/2014 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING UPDATES TO INCORPORATE THE LONG-TERM DATA FROM THE FECAL INCONTINENCE POST-APPROVAL STUDY INTO THE INTERSTIM® THERAPY LABELING. |