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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 SR AND DR, ESPRIT SR AND DR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantSORIN GROUP CRM USA, INC
PMA NumberP950029
Supplement NumberS078
Date Received02/25/2013
Decision Date03/26/2013
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 
Changes to the process limits for gases used to fill finished devices and also updates to the gas concentration limits within the internal atmosphere for the implantable pulse generators.
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