PMA P150012S175

Device: ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331)
Applicant: Boston Scientific
PMA number: P150012
Supplement: S175
Product code: LWP
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries

Current openFDA PMA Record#

Device: ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331)
Applicant: Boston Scientific
PMA number: P150012
Supplement: S175
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries