PMA P150012S132

Device: MRI Pacemakers
Applicant: Boston Scientific
Product code: LWP
Decision date: 2022-12-12
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.

Current openFDA PMA Record#

Device: MRI Pacemakers
Applicant: Boston Scientific
PMA number: P150012
Supplement: S132
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2022-12-12
Decision code: APPR
Date received: 2022-09-30
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.