PMA N970003S301

Device: Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101,
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S301
Product code: LWP
Decision date: 2026-01-08
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer

Current openFDA PMA Record#

Device: Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101,
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S301
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-01-08
Decision code: APPR
Date received: 2025-07-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer