Approval for the morcher cionni capsular tension rings (types 1l, 2l, and 2c). The device is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e. G. , marfan's syndrome), secondary zonular weakness (e. G. , trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of marchesani's syndrom.
| Device | CIONNI CAPSULAR TENSION RINGS |
| Generic Name | Ring, Endocapsular |
| Applicant | MORCHER GMBH |
| Date Received | 2004-08-03 |
| Decision Date | 2005-10-14 |
| PMA | P010059 |
| Supplement | S002 |
| 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 | 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