PMA P150012S185

Device: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Applicant: Boston Scientific
PMA number: P150012
Supplement: S185
Product code: LWP
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices

Current openFDA PMA Record#

Device: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Applicant: Boston Scientific
PMA number: P150012
Supplement: S185
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices