|
Device | SACRAL NERVE STIMULATION - URINARY IMPLANTABLE NEUROSTIMULATORS |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE, N.E. MINNEAPOLIS, MN 55432 |
PMA Number | P970004 |
Supplement Number | S138 |
Date Received | 07/23/2012 |
Decision Date | 12/03/2012 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS. |