Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
FDA premarket approval P110042/S174 · decided 2022-12-12
Approval details
- PMA number
- P110042
- Supplement
- S174
- Supplement type
- Real-Time Process
- 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
- 2022-09-30
- Decision date
- 2022-12-12
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.
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