EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator
FDA premarket approval P110042/S181 · decided 2023-06-15
Approval details
- PMA number
- P110042
- Supplement
- S181
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-03-27
- Decision date
- 2023-06-15
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for software (SW) changes to the EMBLEM subcutaneous implantable cardioverter defibrillator (S-ICD) Programmer SW Application Models 2877 and 3877, and firmware (FW) changes to the EMBLEM Pulse Generator (PG) FW.
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