| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US |
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| Generic Name | Ring, endocapsular |
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| Applicant | OPHTEC BV
Schweitzerlaan 15
Groningen 9728 |
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| PMA Number | P030023 |
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| Date Received | 06/17/2003 |
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| Decision Date | 04/27/2004 |
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| Product Code |
MRJ |
| Docket Number | 04M-0248 |
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| Notice Date | 05/26/2004 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S004 S005 S006 S007 S008 S011 |
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