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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 AND ESPIRIT FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantSORIN GROUP CRM USA, INC
PMA NumberP950029
Supplement NumberS075
Date Received02/19/2013
Decision Date03/13/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for reinforcement of an existing 100% in-process screening step intended to be applied for a limited quantity of three (3) identified lots.
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