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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 VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantSORIN GROUP CRM USA, INC
PMA NumberP980049
Supplement NumberS087
Date Received09/11/2013
Decision Date10/02/2013
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to the routine bioburden monitoring before sterilization.
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