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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREPLY/ESPRIT
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantSORIN CRM USA, INC.
PMA NumberP950029
Supplement NumberS065
Date Received01/05/2012
Decision Date02/02/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional oven, an updated cleaning process, and an update to the rework process.
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