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 FAMILY OF ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S202 |
Date Received | 02/17/2009 |
Decision Date | 03/23/2009 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS. |
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