OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
FDA premarket approval P030023/S001 · decided 2011-12-14
Approval details
- PMA number
- P030023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2011-10-19
- Decision date
- 2011-12-14
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- 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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