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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 NumberS001
Date Received01/20/2004
Decision Date03/15/2004
Product Code
MRJ[ Registered Establishments with MRJ ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a private label distributor agreement with alcon laboratories, inc. , fort worth, texas. The device will be marketed under the trade name alcon reform capsular tension rings (models actr10, actr11, and actr12).