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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 SR, REPLY DR, ESPIRIT SR, ESPIRIT DR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP950029
Supplement NumberS080
Date Received07/15/2013
Decision Date08/13/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS.
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