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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.
 
DeviceST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS146
Date Received02/05/2010
Decision Date05/03/2010
Product Code NIK 
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
Approval Order Statement  
APPROVAL FOR: 1) THE ADDITION OF THE PACING SYSTEMS ANALYZER (PSA) MODEL EX3100. THE MODEL EX3100 ALSO INCLUDES ACCESSORIES: A) MERLIN ANTENNA ADAPTER EX3190; B) MERLIN CABLE ADAPTER EX3170; AND C) MERLIN ¿M¿ ADAPTER EX3180; AND 2) THE ADDITION OF THE MODEL 3330 VERSION 10.1.1 SOFTWARE.
Approval OrderApproval Order
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