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 | DEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S001 |
Date Received | 10/15/1999 |
Decision Date | 05/18/2000 |
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 Defender IV DR Model 612. |
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