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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.
 
DeviceFRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP030035
Supplement NumberS098
Date Received07/11/2012
Decision Date04/10/2014
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
Approval Order Approval Order
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