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, MULTILOG & SENSORITHM PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S101 |
Date Received | 07/13/2006 |
Decision Date | 08/09/2006 |
Withdrawal Date
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06/20/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS. |
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