Regulatory filing
fda_warning_letter (us_fda)
FDA Warning Letter to Intuitive Surgical (2013) over late / inadequate reporting of da Vinci device corrections and adverse events.
fda warning letter · closed
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-warning-letter-intuitive-2013.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/72800768-0a3f-4135-ab5d-b31e17b2292f
- Revision history: /regulatory-filings/fda-warning-letter-intuitive-2013/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda warning letter
- Status
- closed
- Filing date
- 2013-07-16
- Verification posture
- verified
- Cap-flag notes
- Issuance date 2013-07-16 per press citing the FDA letter (original 2013 letter de-listed from the live FDA database).
Applicant
Covered models (1)
Sources (1)
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Identity
72800768-0a3f-4135-ab5d-b31e17b2292f