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 | EPIC HF / ATLAS + HF FAMILY OF CRT-DS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S119 |
Date Received | 03/04/2009 |
Decision Date | 04/14/2009 |
Product Code |
NIK |
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 MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS FOR ATLAS, +/II, CURRENT AND PROMOTE, RF/+ HE (36 J) AND EPIC, +/II CURRENT AND PROMOTE, RF/+ SE (30 J) FAMILIES OF ICD/CRT-D DEVICES. |
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