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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 NameOVATIO VR AND OVATIO DR ICDS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS051
Date Received11/16/2009
Decision Date12/14/2009
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 
Change in the location for manufacturing the hybrid electronic module component.
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