|
Device | INTERSTIM SACRAL NERVE STIMULATION 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 | S021 |
Date Received | 08/15/2011 |
Decision Date | 10/11/2011 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF POST-APPROVAL PROTOCOL. |