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.
| Device | KARL STORZ D-Light C PDD System |
| Generic Name | Light Source System, Diagnostic Endoscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC.2151 E. Grand Ave.el Segundo, CA 90245 PMA NumberP050027 Supplement NumberS030 Date Received02/16/2022 Decision Date03/17/2022 Product Code OAY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-16 |
| Decision Date | 2022-03-17 |
| PMA | P050027 |
| Supplement | S030 |
| 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 PMA NumberP050027 Supplement NumberS030 Date Received02/16/2022 Decision Date03/17/2022 Product Code OAY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Manufacturing Change To Transfer The PDD Cystoscope Monocoil To A Vertebrae Weld And The PDD Cystoscope Screw Tube Sub-assembly Weld To Be Welded By The Welder In The Pilot Production Room |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 04048551423547 | P050027 | 000 |
| 04048551063910 | P050027 | 000 |
| 04048551064092 | P050027 | 000 |
| 04048551073094 | P050027 | 000 |
| 04048551073131 | P050027 | 000 |
| 04048551073209 | P050027 | 000 |
| 04048551289532 | P050027 | 000 |
| 04048551402528 | P050027 | 000 |
| 04048551402535 | P050027 | 000 |
| 04048551423516 | P050027 | 000 |
| 04048551004654 | P050027 | 000 |
| 04048551350652 | P050027 | 001 |
| 04048551064160 | P050027 | 001 |