CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P940007/S006 · decided 2001-04-02
Approval details
- PMA number
- P940007
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Advanced Medical Optics, Inc.
- Date received
- 2000-09-05
- Decision date
- 2001-04-02
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR STERILIZING THE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 912, AT THE FACILITY IN GRONINGEN, THE NETHERLAND AND FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS FOR MODEL 912 FROM 100% ETHYLENE OXIDE (ET0) TO 20 % ET0/80% CARBON DIOXIDE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
| ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) | Advanced Medical Optics, Inc. | 2008-10-02 |
| THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366) | Advanced Medical Optics, Inc. | 2006-04-07 |
| LENS PLUS REWETTING DROPS (K042562) | Advanced Medical Optics, Inc. | 2005-07-29 |
| SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648) | Advanced Medical Optics, Inc. | 2005-04-05 |
| COMPLETE BLINK-N-CLEAN LENS DROPS (K040839) | Advanced Medical Optics, Inc. | 2004-10-19 |
| BLINK CL LUBRICANT EYE DROPS (K032030) | Advanced Medical Optics, Inc. | 2003-09-25 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092) | Advanced Medical Optics, Inc. | 2003-04-04 |