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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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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