PMA N970003S278

Device: Non-MRI Pacemakers
Applicant: Boston Scientific Corp
Product code: LWP
Decision date: 2022-12-12
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for a supplier site change and the addition of the antioxidant Butylated Hydroxytoluene to a material used in core assemblies for pulse generators.

Current openFDA PMA Record#

Device: Non-MRI Pacemakers
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S278
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 a supplier site change and the addition of the antioxidant Butylated Hydroxytoluene to a material used in core assemblies for pulse generators.