PMA P150012S169

Device: Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models:
Applicant: Boston Scientific
PMA number: P150012
Supplement: S169
Product code: LWP
Decision date: 2026-01-08
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer

Current openFDA PMA Record#

Device: Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models:
Applicant: Boston Scientific
PMA number: P150012
Supplement: S169
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-01-08
Decision code: APPR
Date received: 2025-07-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer