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 | SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S088 |
Date Received | 04/15/2014 |
Decision Date | 05/29/2014 |
Withdrawal Date
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05/07/2018 |
Product Code |
NIK |
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 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650. |
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