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Device | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL |
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 | S116 |
Date Received | 07/08/2016 |
Decision Date | 08/05/2016 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the labeling to correct and modify instructions regarding the use of the cycling feature and its impact on battery longevity. |