|
Device | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA |
Generic Name | SYSTEM, IMAGING, FLUORESCENCE |
Applicant | NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 MISSISSAUGA, ONTARIO L4W 4 |
PMA Number | P950042 |
Supplement Number | S007 |
Date Received | 12/01/2011 |
Decision Date | 02/02/2012 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE MEDICAL DEVICE FROM PINPOINT TO ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA. |