| Note: 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. |
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| Device | ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) |
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| Generic Name | SYSTEM, IMAGING, FLUORESCENCE |
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| Applicant | NOVADAQ TECHNOLOGIES, INC.
2585 SKYMARK AVENUE, STE. 306
MISSISSAUGA, ONTARIO L4W 4 |
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| PMA Number | P950042 |
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| Supplement Number | S003 |
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| Date Received | 09/30/2004 |
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| Decision Date | 06/30/2005 |
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| Product Code |
MRK |
| Docket Number | 05M-0284 |
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| Notice Date | 07/18/2005 |
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| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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