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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 RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP060027
Supplement NumberS053
Date Received08/21/2013
Decision Date03/06/2014
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
Approval OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
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