Subcutaneous Implantable Cardioverter Defibrillator
FDA premarket approval P110042/S145 · decided 2020-09-10
Approval details
- PMA number
- P110042
- Supplement
- S145
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Subcutaneous Implantable Cardioverter Defibrillator
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-08-25
- Decision date
- 2020-09-10
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a 30-minute dwell time step after all sterilization loads for S-ICD pulse generators.
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