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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 NumberS004
Date Received11/08/2011
Decision Date05/23/2013
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 expansion of your family of capsular tension rings (ctrs) available pre-loaded on the eyejet injector to include new ctr models type 10g, 10l, 15, 15a, and 15b. In addition, you requested approval to supply currently approved ctr type 10c as pre-loaded on the eyejet injector.