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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.
 
DeviceMERLIN HOME 6.1M
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 NumberS307
Date Received10/15/2012
Decision Date12/19/2012
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
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER AND SOFTWARE VERSION 6.0 FOR MERLIN.NET SYSTEM.
Approval Order Approval Order
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