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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.
 
DeviceICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS295
Date Received05/25/2012
Decision Date08/09/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
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 OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
Approval Order Approval Order
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