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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.
 
DeviceD010 INOGEN™ MINI ICD VR,D011 INOGEN™ MINI ICD VR,D012 INOGEN™ MINI ICD DR,D013 INOGEN™ MINI ICD DR,D020 DYNAGEN™ MINI I
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960040
Supplement NumberS511
Date Received09/30/2025
Decision Date10/22/2025
Product Code LWS 
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  
to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies
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