|
Device | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY 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 | S092 |
Date Received | 04/20/2015 |
Decision Date | 10/04/2016 |
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 a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I) and 12 month data from the ongoing, nonrandomized study cohort (Phase II). |