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 | META PACEMAKER |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880038 |
Supplement Number | S037 |
Date Received | 06/07/2006 |
Decision Date | 07/11/2006 |
Withdrawal Date
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06/20/2007 |
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 MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER. |
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