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 | S175 |
Date Received | 05/09/2008 |
Decision Date | 06/24/2008 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES. |
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