ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
FDA premarket approval P950042/S003 · decided 2005-06-30
Approval details
- PMA number
- P950042
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Applicant
- Novadaq Technologies, Inc.
- Date received
- 2004-09-30
- Decision date
- 2005-06-30
- Days to decision
- 273 days
- Decision code
- APPR
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Mississauga, Ontario
- Statement
- APPROVAL FOR THE ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE). THIS DEVICE IS INDICATED FOR USE WITH FLUORESCENCE IMAGING DURING BRONCHOSCOPY AS AN ADJUNCT TO WHITE LIGHT IMAGING, TO DETECT AND LOCALIZE TISSUE SUSPICIOUS FOR MODERATE OR SEVERE DYSPLASIA, CARCINOMA IN SITU, OR INVASIVE CANCER IN PATIENTS WITH SUSPECTED OR PREVIOUSLY TREATED LUNG CANCER.
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