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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.
 
DeviceOVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP980049
Supplement NumberS062
Date Received12/16/2010
Decision Date02/10/2011
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE CHANGES OF THE TRANSFORMER (T413), OPTO WEDGE (G309), AND DESICCANT (J907) FOR THE PARADYM ICD AND CRT-D MODELS 8250, 8550, AND 8750.
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