EMBLEM S-ICD Automated Screening Tool
FDA premarket approval P110042/S129 · decided 2019-12-16
Approval details
- PMA number
- P110042
- Supplement
- S129
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM S-ICD Automated Screening Tool
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-10-15
- Decision date
- 2019-12-16
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Automatic Screening Tool on the Model 3300 LATITUDE Programming System and associated changes to the existing programming system support software Multiple Application Utility and Data Manager.
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