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 | CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S160 |
Date Received | 10/22/2007 |
Decision Date | 12/07/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MERLIN.NET VERSION 2.5. IT CONSISTS OF THE MATRIX PCS RELEASE 2.5, WHICH IS THE HOUSECALL RECEIVER SOFTWARE, VERSION 4000-3.5.1 AND THE RECEIVER MANAGER SOFTWARE. |
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