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, MODEL V-100 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S112 |
Date Received | 06/26/2006 |
Decision Date | 07/11/2006 |
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 THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE. |
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