PMA P150012S180

Device: IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Applicant: Boston Scientific
PMA number: P150012
Supplement: S180
Product code: LWP
Decision date: 2026-03-06
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.

Current openFDA PMA Record#

Device: IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Applicant: Boston Scientific
PMA number: P150012
Supplement: S180
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-03-06
Decision code: APPR
Date received: 2026-01-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.