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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.
 
Trade NameMERLIN PATIENT CARE SYSTEM MODEL 3650
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP030054
Supplement NumberS008
Date Received04/18/2005
Decision Date10/12/2005
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the merlin patient care system with the model 3330 version 1. 0 software.
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