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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.
 
DeviceALCON REFORM CAPSULAR TENSION RING
Classification Namering, endocapsular
Generic Namering, endocapsular
Applicant
MORCHER GMBH
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).
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