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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™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS178
Date Received12/18/2025
Decision Date03/18/2026
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the INGEVITY+ passive fixation pace/sense lead models 7831, 7832, 7835, and 7836, and for a sterilization site change impacting these lead models.
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