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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 NameImplantable cardioverter defibrillator (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP880006
Supplement NumberS072
Date Received06/28/2011
Decision Date08/17/2011
Withdrawal Date05/07/2018
Product Codes LWP LWS NIK NKE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
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