Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OVATIO VR 6250 AND OVATIO DR 6550 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S040 |
Date Received | 08/13/2008 |
Decision Date | 10/31/2008 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE AUTOMATIC SENSITIVITY CONTROL (ASC) ALGORITHM IN THE OVATIO VR 6250, OVATIO DR 6550 AND OVATIO CRT 6750. |
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