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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.
 
DeviceINCEPTA ENERGEN PUNCTUA COGNIS, LIVIAN FAMILIES
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS329
Date Received05/08/2013
Decision Date06/06/2013
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE.
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