Latitude NXT Patient Management System (EMBLEM S-ICD)
FDA premarket approval P110042/S195 · decided 2024-07-18
Approval details
- PMA number
- P110042
- Supplement
- S195
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Latitude NXT Patient Management System (EMBLEM S-ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-04-19
- Decision date
- 2024-07-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- server and communicator software updates for the LATITUDE NXT System including both LATITUDE Wave Communicator model 6290 and LATITUDE NXT Server Software model 6460.
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