PMA P950042S003
- Device
- ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
- Applicant
- Novadaq Technologies, Inc.
- PMA number
- P950042
- Supplement
- S003
- Product code
- MRK
- Decision date
- 2005-06-30
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950042S003B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
- Applicant
- Novadaq Technologies, Inc.
- PMA number
- P950042
- Supplement
- S003
- Product code
- MRK
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Decision date
- 2005-06-30
- Decision code
- APPR
- Date received
- 2004-09-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.