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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 VR 8750,PARADYM DR8750,PARADYM RF VR 9750,PARADYM RF DR 9750
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS086
Date Received09/11/2013
Decision Date09/26/2013
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.
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