|
Device | INTERSTIM THERAPY SYSTEM (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 | S127 |
Date Received | 11/21/2016 |
Decision Date | 12/15/2016 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Transfer of existing passivation process and corrosion testing to RMS Medical and addition of hydrofluoric acid cleaning step prior to passivation of leads, extensions, and accessories. |