PMA N970003S280

Device: Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S280
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: Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S280
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2022-12-12
Decision code: APPR
Date received: 2022-10-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.