|
Device | LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT AND LEAD |
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 | S048 |
Date Received | 02/11/2013 |
Decision Date | 12/06/2016 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the tubing material from the prior MDX silicone resin to the NuSil MED 4719 silicone resin. |