MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P810055/S066 · decided 1998-02-02
Approval details
- PMA number
- P810055
- Supplement
- S066
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Advanced Medical Optics, Inc.
- Date received
- 1996-05-23
- Decision date
- 1998-02-02
- Days to decision
- 620 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for the use of an alternate sterilizer at the manufacturing site in Groningen, The Netherlands.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |