LATITUDE NXT Release 7.3
FDA premarket approval P910077/S191 · decided 2023-04-21
Approval details
- PMA number
- P910077
- Supplement
- S191
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE NXT Release 7.3
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-01-23
- Decision date
- 2023-04-21
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for software and cybersecurity changes for the LATITUDE NXT Release 7.3.
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