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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP880006
Supplement NumberS078
Date Received02/29/2012
Decision Date03/21/2012
Withdrawal Date05/07/2018
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS.
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