PMA P150012S176

Device: INGEVITY™ MRI tined and extendable/retractable fixation leads / INGEVITY+™ leads
Applicant: Boston Scientific
PMA number: P150012
Supplement: S176
Product code: LWP
Decision date: 2026-02-20
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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

Current openFDA PMA Record#

Device: INGEVITY™ MRI tined and extendable/retractable fixation leads / INGEVITY+™ leads
Applicant: Boston Scientific
PMA number: P150012
Supplement: S176
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-02-20
Decision code: APPR
Date received: 2025-12-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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