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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 NamePARADYM RF VR
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantSORIN GROUP- CRM
PMA NumberP980049
Supplement NumberS095
Date Received03/24/2014
Decision Date04/16/2014
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes for the devices (platform zl102): 1) added equipment cooler stacker/de-stacker used in the electronic smd assembly line; 2) laser welding process rework for visual defect on case; and 3. Paradym rf (zl102), in sourcing of rf module manufacturing.
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