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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 AND DR, PARADYM RF VR AND DR
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantSORIN GROUP ITALIA S.R.L.
PMA NumberP980049
Supplement NumberS081
Date Received02/25/2013
Decision Date03/26/2013
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the process limits for gases used to fill finished devices and also updates to the gas concentration limits within the internal atmosphere for the implantable pulse generators.
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