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Device | OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S061 |
Date Received | 11/29/2010 |
Decision Date | 12/21/2012 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE LABELING OF THE DEVICES BASED ON THE POST-APPROVAL STUDY RESULTS. |