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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.
 
Trade NameOPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
Classification Namering, endocapsular
Generic Nameendocapsular tension ring
ApplicantOPHTEC USA, INC.
PMA NumberP030023
Supplement NumberS001
Date Received10/19/2011
Decision Date12/14/2011
Product Code
MRJ[ Registered Establishments with MRJ ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change. The device, as modified, will be marketed under the trade name ophtec capsular tension ring models 276 and 275 and is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.
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