PMA P150012S129

Device: ESSENTIO™ MRI, PROPONENT™ MRI, ACCOLADE™ MRI
Applicant: Boston Scientific
Product code: LWP
Decision date: 2022-11-08
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for a software maintenance release to update the Model 3869 Brady programmer software application and Accolade pulse generator firmware.

Current openFDA PMA Record#

Device: ESSENTIO™ MRI, PROPONENT™ MRI, ACCOLADE™ MRI
Applicant: Boston Scientific
PMA number: P150012
Supplement: S129
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2022-11-08
Decision code: APPR
Date received: 2022-08-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software maintenance release to update the Model 3869 Brady programmer software application and Accolade pulse generator firmware.