Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
FDA premarket approval P110042/S189 · decided 2023-12-13
Approval details
- PMA number
- P110042
- Supplement
- S189
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-09-15
- Decision date
- 2023-12-13
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for a design change to the outer epoxy sleeve of S-ICD pulse generator headers to reduce bubble formation
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