|
Device | SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY |
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 | S065 |
Date Received | 03/13/2014 |
Decision Date | 04/11/2014 |
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 ADDITIONAL IN-PROCESS INSPECTIONS AND TOOLING CHANGES IN THE MANUFACTURING PROCESS OF A COMPONENT OF THE INTERSTIM II NEUROSTIMULATOR, AT THE MEDTRONIC ENERGY AND COMPONENT CENTER. |