PMA P150012S112

Device: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Applicant: Boston Scientific
Product code: LWP
Decision date: 2021-09-03
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for the addition of Platinum/Iridium feedthru wires as an alternate to the Palladium/Iridium feedthru wires used in the Filtered Feedthru Assembly and minor design changes updating the extended life battery stack insulator.

Current openFDA PMA Record#

Device: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Applicant: Boston Scientific
PMA number: P150012
Supplement: S112
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2021-09-03
Decision code: APPR
Date received: 2021-06-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of Platinum/Iridium feedthru wires as an alternate to the Palladium/Iridium feedthru wires used in the Filtered Feedthru Assembly and minor design changes updating the extended life battery stack insulator.