This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the karl storz autofluorescence system. The karl storz autofluorescence system is indicated for use in white light and autofluorescence bronchoscopy to identify and locate abnormal bronchial tissue for biopsy and histological evaluation. It is indicated in patients who: 1) are suspected of having bronchogenic carcinoma and are scheduled for a bronchoscopy as part of a standard diagnostic staging or work-up 2) have been previously diagnosed with lung cancer and who are at high risk for recurrence 3) have abnormal sputum cytology 4) have abnormal chest x-ray, ct scan or similar technology.
| Device | KARL STORZ AUTOFLUORESCENCE SYSTEM |
| Generic Name | System, Imaging, Fluorescence |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 2002-03-07 |
| Decision Date | 2002-12-12 |
| Notice Date | 2003-01-22 |
| PMA | P020008 |
| Supplement | S |
| Product Code | MRK |
| Docket Number | 03M-0011 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 Corporate Pointe culver City, CA 90230-7600 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020008 | Original Filing | |
| S002 | 2009-10-22 | Real-time Process |
| S001 | 2005-02-07 | 30-day Notice |