Approval of corrections to the ethylene oxide (eto) sterilization instructions contained in the pdd camera heads instruction card, hopkins ii pdd telescopes instruction manual and tricam sl ii camera control unit instruction manual.
| Device | KARL STORZ PHOTODYNAMIC 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 | 2012-08-21 |
| Decision Date | 2012-09-10 |
| PMA | P050027 |
| Supplement | S004 |
| Product Code | OAY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. Grand Ave. el Segundo, CA 90245 |
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