This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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.
| Device | 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 |
| Notice Date | 2005-07-18 |
| PMA | P950042 |
| Supplement | S003 |
| Product Code | MRK |
| Docket Number | 05M-0284 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NOVADAQ TECHNOLOGIES, INC. 2585 Skymark Avenue, Ste. 306 mississauga, Ontario L4W 4 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950042 | Original Filing | |
| S007 | 2011-12-01 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | ||
| S004 | 2007-07-18 | Normal 180 Day Track No User Fee |
| S003 | 2004-09-30 | Panel Track |
| S002 | ||
| S001 | 1998-04-30 | Normal 180 Day Track |