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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.
 
DeviceORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960040
Supplement NumberS358
Date Received11/04/2015
Decision Date11/19/2015
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
AUTOMATION OF THE STERILE PACKAGING PROCESS.
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