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 a change in the trade name of the medical device from pinpoint to onco-life endoscopic light source and video camera.
| Device | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA |
| Generic Name | System, Imaging, Fluorescence |
| Applicant | NOVADAQ TECHNOLOGIES, INC. |
| Date Received | 2011-12-01 |
| Decision Date | 2012-02-02 |
| PMA | P950042 |
| Supplement | S007 |
| Product Code | MRK |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
| 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 |