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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.
 
DevicePARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP060027
Supplement NumberS011
Date Received02/20/2009
Decision Date10/27/2009
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE. THE DEVICE IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING ARRHYTHMIAS. THE DEVICE IS ALSO INDICATED FOR THE REDUCTION OF HEART FAILURE SYMPTOMS IN MEDICALLY OPTIMIZED NYHA FUNCTIONAL CLASS III AND IV PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION OF 35% OR LESS, AND A QRS DURATION OF 150 MS OR LONGER.
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