Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
FDA premarket approval P110042/S186 · decided 2023-07-07
Approval details
- PMA number
- P110042
- Supplement
- S186
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-06-29
- Decision date
- 2023-07-07
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Remove an incoming inspection for the presence of Lithium Perchlorate in battery electrolyte.
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| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
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| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
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