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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.
 
DevicePUNCTUA CRT-D, ENERGEN CRT-D, INCEPTA CRT-D
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS291
Date Received05/11/2012
Decision Date06/19/2012
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFYING THE DESIGN SPECIFICATIONS FOR THE SPOT WELD ANCHOR POST USED IN ICD AND CRT-D PULSE GENERATOR (PG) HEADERS AND THE LEAF SPRING HOUSING BLOCK USED IN THE LV-1 FOR CRT-D PULSE GENERATOR HEADERS.
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