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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 ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161,
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960040
Supplement NumberS252
Date Received02/09/2012
Decision Date03/15/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes and associated manufacturing changes to the punctua/ incepta/ energen hybrid assembly.
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