Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the letter dated october 10, 2019 requesting that you continue the assessment of subjects implanted with the device for a minimum of 10 years to assess the long-term safety profile of the cypass® system.
| Device | CyPass Micro-Stent |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Alcon Research, Ltd |
| Date Received | 2019-12-20 |
| Decision Date | 2020-04-09 |
| PMA | P150037 |
| Supplement | S014 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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