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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS146
Date Received02/05/2010
Decision Date05/03/2010
Product Code
NIK[ Registered Establishments with NIK ]
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: 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 Order Approval Order
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