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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceMORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
Classification Namering, endocapsular
Generic Namering, endocapsular
Applicant
MORCHER GMBH
kapuzinerweg 12
stuttgart, wurttemberg-baden D-703-7037
PMA NumberP010059
Date Received10/16/2001
Decision Date10/23/2003
Product Code
MRJ[ Registered Establishments with 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
Supplements: S001 S002 S003 S004 S006 
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