This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the xillix life-lung fluorescence endoscopy system
| Device | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA |
| Generic Name | System, Imaging, Fluorescence |
| Applicant | NOVADAQ TECHNOLOGIES, INC. |
| Date Received | 1995-12-22 |
| Decision Date | 1996-09-19 |
| Notice Date | 1997-04-01 |
| PMA | P950042 |
| Supplement | S |
| Product Code | MRK |
| Docket Number | 97M-0122 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NOVADAQ TECHNOLOGIES, INC. 2585 Skymark Avenue, Ste. 306 mississauga, Ontario L4W 4 |
| 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 |