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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namering, endocapsular
Generic Namering, endocapsular
kapuzinerweg 12
stuttgart, wurttemberg-baden D-703-7037
PMA NumberP010059
Supplement NumberS002
Date Received08/03/2004
Decision Date10/14/2005
Product Code
MRJ[ Registered Establishments with MRJ ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.