Addition of the sinking spring, pa facility as an alternative manufacturing site for the cypass ultra system and implement changes to the inspection test methods and acceptance criteria for the stent delivery system.
| Device | CyPass Ultra System |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Alcon Research, Ltd |
| Date Received | 2018-06-25 |
| Decision Date | 2018-07-23 |
| PMA | P150037 |
| Supplement | S010 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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