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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.
 
DeviceNG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960040
Supplement NumberS320
Date Received06/17/2014
Decision Date08/26/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE TRANSFORMER USED IN THE NG3 FAMILY OF DEVICES.
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