Change in an epoxy manufacturing material used in the manufacturing process of the transformer in the telecam and tricam.
| Device | KARL STORZ D-Light C PDD System |
| Generic Name | Light Source System, Diagnostic Endoscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 2021-09-09 |
| Decision Date | 2021-10-13 |
| PMA | P050027 |
| Supplement | S029 |
| Product Code | OAY |
| Advisory Committee | Gastroenterology/Urology |
| 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. 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