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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.
 
DeviceINGEVITY™ MRI tined and extendable/retractable fixation leads / INGEVITY+™ leads
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS176
Date Received12/02/2025
Decision Date02/20/2026
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to transfer the 100% ethylene oxide (EO) gas sterilization process for the CRM leads from BSC's Dorado, Puerto Rico site to BSC's Coventry, Rhode Island site
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