Approval to include the ringject, a disposable injector/delivery system designed for use with capsular tension rings (ctrs), addition of the injector into the same sterile packaging process as the ctr and modification of the packaging configuration to accommodate the combined injector and the preloaded ctr. The device, as modified, will be marketed under the trade name ringject, model 375 and model 376. Ctrs are indicated for the stabilization of weakened, broken, or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curbilinear capsulorhexis techniques in adults.
| Device | CAPSULAR TENSION RING AND STABILEYES |
| Classification Name | Ring, Endocapsular |
| Generic Name | Ring, Endocapsular |
| Applicant | OPHTEC USA, INC. |
| Date Received | 2014-07-21 |
| Decision Date | 2015-11-13 |
| PMA | P030023 |
| Supplement | S004 |
| Product Code | MRJ |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPHTEC USA, INC. 6421 Congress Ave., Suite 112 boca Raton, FL 33487 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030023 | | Original Filing |
| S008 |
2022-02-08 |
30-day Notice |
| S007 |
2018-12-18 |
30-day Notice |
| S006 | | |
| S005 |
2016-06-10 |
30-day Notice |
| S004 |
2014-07-21 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2012-01-05 |
135 Review Track For 30-day Notice |
| S001 |
2011-10-19 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices