OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
FDA premarket approval P030023 · decided 2004-04-27
Approval details
- PMA number
- P030023
- Trade name
- OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2003-06-17
- Decision date
- 2004-04-27
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- 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.
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