|
Device | CAPSURE EPICARDIAL PACING LEAD, 4665, 4968 |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P950024 |
Supplement Number | S042 |
Date Received | 08/03/2012 |
Decision Date | 08/30/2012 |
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 | Yes |
Approval Order Statement MODIFICATIONS TO A CONTROLLED ENVIRONMENT. |
Post-Approval Study | Show Report Schedule and Study Progress |