- Device
- EMBLEM S-ICD pulse generator (PG) Models A209/A219
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S161
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-11-16
- Decision code
- APPR
- Date received
- 2021-09-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the hydrogen getter, transformer spacer component, and desiccant liner component of the EMBLEM S-ICD pulse generator Models A209/A219.