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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.
 
DeviceQUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS281
Date Received12/18/2014
Decision Date02/25/2015
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
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