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 | IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S110 |
Date Received | 10/07/2005 |
Decision Date | 01/31/2006 |
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 AN ALTERNATE ORGANIC FEEDTHRU SUBSTRATE TO BE USED IN THE AFFINITY, ENTITY, IDENTITY, IDENTITY ADX, INTEGRITY AND VERITY FAMILIES OF PULSE GENERATORS. |
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