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.
Change in the oem sensor for the karl storz autofluorescence system.
| Device | KARL STORZ AUTOFLURESCENCE SYSTEM |
| Generic Name | System, Imaging, Fluorescence |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-04 |
| PMA | P020008 |
| Supplement | S001 |
| Product Code | MRK |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 Corporate Pointe culver City, CA 90230-7600 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020008 | Original Filing | |
| S002 | 2009-10-22 | Real-time Process |
| S001 | 2005-02-07 | 30-day Notice |