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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
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP910023
Supplement NumberS307
Date Received10/15/2012
Decision Date12/19/2012
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
RecallsCDRH 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 OrderApproval Order
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