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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.
 
DeviceG124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS584
Date Received05/17/2024
Decision Date05/29/2024
Product Code NIK 
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 add an alternate Sterile Pack Automation system at the Boston Scientific Clonmel manufacturing site
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