Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C |
Generic Name | Ring, endocapsular |
Applicant | MORCHER GMBH KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-703-7037 |
PMA Number | P010059 |
Date Received | 10/16/2001 |
Decision Date | 10/23/2003 |
Product Code |
MRJ |
Docket Number | 04M-0022 |
Notice Date | 01/21/2004 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C. 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 SYNDROME. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S006 S007 S010 S011 S012 |
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