PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
FDA premarket approval P950042/S007 · decided 2012-02-02
Approval details
- PMA number
- P950042
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 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
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Mississauga, Ontario
- Statement
- APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE MEDICAL DEVICE FROM PINPOINT TO ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPY Phi Open Field Handheld Fluorescence Imaging System (K162885) | Novadaq Technologies, Inc. | 2017-01-11 |
| PINPOINT Endoscopic Fluorescence Imaging System (K161792) | Novadaq Technologies, Inc. | 2016-09-20 |
| PINPOINT Endoscopic Fluorescence Imaging System (K150956) | Novadaq Technologies, Inc. | 2016-05-23 |
| ENDOSCOPIC INTRODUCER (K123013) | Novadaq Technologies, Inc. | 2013-03-22 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM (K100371) | Novadaq Technologies, Inc. | 2011-02-04 |
| SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (K091515) | Novadaq Technologies, Inc. | 2009-07-09 |
| SPY ANALYSIS TOOLKIT, MODEL SA9000 (K081792) | Novadaq Technologies, Inc. | 2008-09-17 |
| SPY FLUORESCENT IMAGING SYSTEM (K073130) | Novadaq Technologies, Inc. | 2008-01-10 |