Approval for design changes to the cypass system 241-s and inclusion of an additional sterilization vendor. The modified design will be marketed as the cypass ultra system.
| Device | CyPass Ultra System |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Alcon Research, Ltd |
| Date Received | 2017-09-25 |
| Decision Date | 2017-12-18 |
| PMA | P150037 |
| Supplement | S008 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd 6201 South Freeway fort Worth, TX 76134 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150037 | | Original Filing |
| S014 |
2019-12-20 |
Normal 180 Day Track No User Fee |
| S013 | | |
| S012 | | |
| S011 |
2018-07-16 |
30-day Notice |
| S010 |
2018-06-25 |
30-day Notice |
| S009 |
2018-05-04 |
30-day Notice |
| S008 |
2017-09-25 |
Normal 180 Day Track |
| S007 |
2017-07-27 |
Normal 180 Day Track No User Fee |
| S006 |
2017-06-02 |
Normal 180 Day Track No User Fee |
| S005 |
2017-04-20 |
30-day Notice |
| S004 |
2017-03-15 |
30-day Notice |
| S003 |
2016-11-03 |
30-day Notice |
| S002 |
2016-08-26 |
Normal 180 Day Track No User Fee |
| S001 |
2016-08-24 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices