|
Device | SNS BOWEL EXTENSIONS, SNS BOWEL LEADS |
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 | S054 |
Date Received | 09/09/2013 |
Decision Date | 10/03/2013 |
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 UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO. |