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 | LYRA(TM) ICD SYSTEMS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MicroPort CRM USA, Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P970024 |
Supplement Number | S004 |
Date Received | 11/30/2000 |
Decision Date | 02/06/2001 |
Withdrawal Date
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10/03/2022 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FIRMWARE MODIFICATIONS IN THE LYRA(TM) ICD SYSTEMS. |
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