Approval for the karl storzphotodynamic diagnostic d-light c (pdd) system. The karl storz photodynamic diagnostic d-lightc (pdd) system in combination with the optical imaging drug cysview(hexaminolevulinate hydrochloride) for intravesical solution is indicated for photodynamic bluelight cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasivepapillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy.
| Device | KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM |
| Classification Name | Light Source System, Diagnostic Endoscopic |
| Generic Name | Light Source System, Diagnostic Endoscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 2005-07-31 |
| Decision Date | 2010-05-28 |
| Notice Date | 2010-06-14 |
| PMA | P050027 |
| Supplement | S |
| Product Code | OAY |
| Docket Number | 10M-0294 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. Grand Ave. el Segundo, CA 90245 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050027 | | Original Filing |
| S030 |
2022-02-16 |
30-day Notice |
| S029 |
2021-09-09 |
30-day Notice |
| S028 | | |
| S027 |
2020-12-10 |
30-day Notice |
| S026 |
2020-12-09 |
30-day Notice |
| S025 |
2020-06-29 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 | | |
| S021 |
2020-05-08 |
30-day Notice |
| S020 |
2020-02-24 |
30-day Notice |
| S019 |
2019-06-25 |
30-day Notice |
| S018 | | |
| S017 |
2019-03-25 |
30-day Notice |
| S016 | | |
| S015 | | |
| S014 |
2018-09-17 |
Real-time Process |
| S013 |
2018-07-20 |
Real-time Process |
| S012 |
2018-04-23 |
30-day Notice |
| S011 |
2017-08-03 |
Normal 180 Day Track |
| S010 |
2017-06-23 |
135 Review Track For 30-day Notice |
| S009 |
2017-06-23 |
135 Review Track For 30-day Notice |
| S008 |
2017-02-15 |
30-day Notice |
| S007 |
2014-08-12 |
30-day Notice |
| S006 |
2014-07-02 |
30-day Notice |
| S005 |
2013-03-18 |
Normal 180 Day Track No User Fee |
| S004 |
2012-08-21 |
Special (immediate Track) |
| S003 |
2012-05-29 |
Real-time Process |
| S002 |
2010-09-24 |
Real-time Process |
| S001 |
2010-06-11 |
Real-time Process |
NIH GUDID Devices