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 | PARAGON/PHOENIX FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S108 |
Date Received | 04/13/2007 |
Decision Date | 05/07/2007 |
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 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER. |
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