EMBLEM S-ICD
FDA premarket approval P110042/S193 · decided 2024-04-30
Approval details
- PMA number
- P110042
- Supplement
- S193
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM S-ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-01-31
- Decision date
- 2024-04-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- a software maintenance release for updates to the Model 3300 LATITUDETM Programming System.
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