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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/ESPRIT SR/DR PACERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP950029
Supplement NumberS056
Date Received01/27/2011
Decision Date03/22/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A NEW SETSCREW AND TORQUE-LIMITING SCREWDRIVER ACCESSORY.
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