|
Device | CAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S081 |
Date Received | 06/28/2011 |
Decision Date | 07/21/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD. |