Subcutaneous ICD Devices
FDA premarket approval P110042/S159 · decided 2021-11-30
Approval details
- PMA number
- P110042
- Supplement
- S159
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Subcutaneous ICD Devices
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-09-03
- Decision date
- 2021-11-30
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a software maintenance release (SMR) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.
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