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 to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.
Device | XILLIX-LIFE-LUNG |
Generic Name | System, Imaging, Fluorescence |
Applicant | NOVADAQ TECHNOLOGIES, INC. |
Date Received | 1998-04-30 |
Decision Date | 1998-07-21 |
PMA | P950042 |
Supplement | S001 |
Product Code | MRK |
Advisory Committee | Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol - Ode/oir |
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 |