MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C

FDA Premarket Approval P010059

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.

Pre-market Approval Supplement Details

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.

• Device: MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
• Generic Name: Ring, Endocapsular
• Applicant: MORCHER GMBH
• Date Received: 2001-10-16
• Decision Date: 2003-10-23
• Notice Date: 2004-01-21
• PMA: P010059
• Supplement: S
• Product Code: MRJ
• Docket Number: 04M-0022
• Advisory Committee: Ophthalmic
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: MORCHER GMBH kapuzinerweg 12 stuttgart, Wurttemberg-baden D-703-7037
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

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

Device ID	PMA	Supp
04048509620004	P010059	007