EMBLEM (Subcutaneous ICD Devices)
FDA premarket approval P110042/S119 · decided 2019-02-22
Approval details
- PMA number
- P110042
- Supplement
- S119
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM (Subcutaneous ICD Devices)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-12-03
- Decision date
- 2019-02-22
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the Server and Communicator software updates necessary for LATITUDE NXT Release.
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