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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.
 
DeviceSENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantSt. Jude Medical, Inc.
15900 Valley View Court
Sylamr, CA 91342
PMA NumberP880006
Supplement NumberS067
Date Received06/04/2010
Decision Date03/04/2011
Withdrawal Date05/07/2018
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Approval OrderApproval Order
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