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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 Court
SYLMAR, CA 91342
PMA NumberP880006
Supplement NumberS087
Date Received11/21/2013
Decision Date02/26/2014
Withdrawal Date 05/07/2018
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
Approval OrderApproval Order
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