Regulatory filing
DEN230078 (us_fda)
FDA De Novo authorization for the CMR Surgical Versius system (initial US indication); reported 2024.
fda de novo · granted · decided 2024-10-11
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-cmr-versius-denovo-2024.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/aad50dce-fe2c-4ff8-b34d-1bfb1b5faf54
- Revision history: /regulatory-filings/fda-cmr-versius-denovo-2024/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda de novo
- Status
- granted
- Filing number
- DEN230078
- Filing date
- 2023-11-21
- Decision date
- 2024-10-11
- Verification posture
- reported
- Cap-flag notes
- Filing number not yet captured; De Novo pathway reported. Upgrade to verified when the DEN-number is confirmed.
Applicant
Covered models (1)
Sources (1)
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Identity
aad50dce-fe2c-4ff8-b34d-1bfb1b5faf54