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 | PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S099 |
Date Received | 02/07/2006 |
Decision Date | 06/26/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE AUTOMATED TEST SOFTWARE (ATE) USED FOR COMPONENT AND SUBASSEMBLY LEVEL TESTING DURING THE MANUFACTURING PROCESS. |
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