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 | GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S036 |
Date Received | 01/06/2006 |
Decision Date | 03/02/2006 |
Withdrawal Date
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05/07/2018 |
Product Codes |
KRG 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 MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER. |
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