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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.
 
DeviceELA MEDICAL'S REPLY PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP950029
Supplement NumberS048
Date Received11/04/2009
Decision Date06/18/2010
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 SOFTWARE VERSIONS W1.5.2 AND W1.5.3 FOR THE REPLY PACEMAKER.
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