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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceOPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
Classification Namering, endocapsular
Generic Namering, endocapsular
Applicant
OPHTEC USA, INC.
6421 congress ave., suite 112
boca raton, FL 33487
PMA NumberP030023
Date Received06/17/2003
Decision Date04/27/2004
Product Code
MRJ[ Registered Establishments with MRJ ]
Docket Number 04M-0248
Notice Date 05/26/2004
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the oculaid capsular tension ring (model 275 10/12 mm and model 276 11/13 mm), also known as the stableyes capsular tension ring (model 275 10/12 mm and model 276 11/13 mm), to be distributed by advanced medical optics. The device 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 
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