MODELS PC-58NBM & PC-58NBZ IOLS
FDA premarket approval P820049/S064 · decided 1997-10-02
Approval details
- PMA number
- P820049
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS PC-58NBM & PC-58NBZ IOLS
- Generic name
- intraocular lens
- Applicant
- Advanced Medical Optics, Inc.
- Date received
- 1997-06-30
- Decision date
- 1997-10-02
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salina, Puerto Rico.
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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 |