|
Device | INTERSTIM THERAPY SYSTEM 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 | S124 |
Date Received | 09/28/2016 |
Decision Date | 10/24/2016 |
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 Addition of an inspection for a concentricity requirement to the strain relief part of the InterStim II Model 3058. |