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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.
 
DeviceREPLY DR & SR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP950029
Supplement NumberS042
Date Received03/04/2009
Decision Date04/02/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING CHANGES TO THE REPLY DR AND REPLY SR IMPLANT MANUALS.
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