|
Device | MEDTRONIC 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 | S068 |
Date Received | 04/21/2014 |
Decision Date | 10/17/2014 |
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 CHANGES TO THE MODEL 3037 ICON PATIENT CONTROLLER USED FOR MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL. |