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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.
 
DeviceALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS167
Date Received07/25/2014
Decision Date10/21/2014
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INGENIO PACEMAKERS (ADVANTIO MODELS K062, K063, K064; INGENIO MODELS K172, K173, K174; VITALIO MODELS K272, K273, K274; FORMIO MODEL K278); INGENIO 2 PACEMAKERS (ALTRUA 2 MODEL: S701, S702, S722; ESSENTIO MODELS L100, L101, L121; PROPONENT MODELS L200, L201, L221; ACCOLADE MODELS L300, L301, L321) AND PROGRAMMER APPLICATION SOFTWARE MODEL 2869 V2.01.
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