FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Imaging, Fluorescence
PMA: P950042
·
Supplement: S003
·
Decision Jun 30, 2005
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- System, Imaging, Fluorescence
- Trade Name
- ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
- PMA Number
- P950042
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MRK
- Generic Name
- SYSTEM, IMAGING, FLUORESCENCE
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 30, 2005
- Date Received
- September 30, 2004
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 05M-0284
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRK | System, Imaging, Fluorescence | FDA class 3 | Unknown |