|
Device | INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS |
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 | S014 |
Date Received | 07/19/2011 |
Decision Date | 08/17/2011 |
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 IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER. |