PMA P150012S178

Device: INGEVITY™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J
Applicant: Boston Scientific
PMA number: P150012
Supplement: S178
Product code: LWP
Decision date: 2026-03-18
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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.

Current openFDA PMA Record#

Device: INGEVITY™+ Pace / Sense Lead – Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J
Applicant: Boston Scientific
PMA number: P150012
Supplement: S178
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-03-18
Decision code: APPR
Date received: 2025-12-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.