PMA P150012S191

Device: ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO
Applicant: Boston Scientific
PMA number: P150012
Supplement: S191
Product code: LWP
Decision date: 2026-10-03
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: to implement an additional acceptance activity for Accolade SL batteries and to change a specification for an existing Accolade EL battery specification

Current openFDA PMA Record#

Device: ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO
Applicant: Boston Scientific
PMA number: P150012
Supplement: S191
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-10-03
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement an additional acceptance activity for Accolade SL batteries and to change a specification for an existing Accolade EL battery specification