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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 NamePUNCTUA CRT-D, ENERGEN CRT-D, INCEPTA CRT-D
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP010012
Supplement NumberS291
Date Received05/11/2012
Decision Date06/19/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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