EMBLEM S-ICD pulse generator (PG) Models A209/A219
FDA premarket approval P110042/S161 · decided 2021-11-16
Approval details
- PMA number
- P110042
- Supplement
- S161
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM S-ICD pulse generator (PG) Models A209/A219
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-09-20
- Decision date
- 2021-11-16
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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