Approval for the addition of capsular tension rings (ctrs) models1g, 2s, 6d, 6e, and 10c and change in packaging to incorporate the morcher injector preloaded with ctr models 14, 14a, and 14c. The device, as modified, will be marketed under the trade name morcher capsular tension rings (models 1g, 2s, 6d, 6e, and 10c) and eyejet ctr and is indicated for the stabilization of the crystalline lens capsule in the presence of weak orpartially absent zonules in adult patients undergoing cataract extraction with intraocular lensimplantation. Conditions associated with weak or partially absent zonules may include primaryzonular weakness (e. G. , marfan's syndrome), secondary zonular weakness (e. G. , trauma orvitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of marchesani¿s syndrome.
| Device | MORCHER CAPSULAR TENSION RINGS |
| Generic Name | Ring, Endocapsular |
| Applicant | MORCHER GMBH |
| Date Received | 2007-03-19 |
| Decision Date | 2009-05-22 |
| PMA | P010059 |
| Supplement | S003 |
| Product Code | MRJ |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MORCHER GMBH kapuzinerweg 12 stuttgart, Wurttemberg-baden D-703-7037 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010059 | | Original Filing |
| S006 |
2016-08-02 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 |
2011-11-08 |
Normal 180 Day Track |
| S003 |
2007-03-19 |
Real-time Process |
| S002 |
2004-08-03 |
Normal 180 Day Track |
| S001 |
2004-01-20 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices