UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
FDA premarket approval P880091/S010 · decided 1997-06-30
Approval details
- PMA number
- P880091
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
- Generic name
- intraocular lens
- Applicant
- Staar Surgical Co.
- Date received
- 1997-03-26
- Decision date
- 1997-06-30
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR LENS MODEL AA-4207VF. THE DEVICE IS TO BE PLACED IN THE CAPSULAR BAG OF THE EYE AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION OR EXTRACAPSULAR CATARACT EXTRACTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EPIPHANY INJECTION SYSTEM (K090161) | Staar Surgical Co. | 2009-06-09 |
| MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (K073591) | Staar Surgical Co. | 2008-03-13 |
| MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586) | Staar Surgical Co. | 2008-03-13 |
| RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412) | Staar Surgical Co. | 2004-06-10 |
| SURGE-FREE ASPIRATION ADAPTER (K020734) | Staar Surgical Co. | 2002-05-16 |
| DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129) | Staar Surgical Co. | 1998-12-04 |
| FOAM TIP INJECTOR (K980696) | Staar Surgical Co. | 1998-09-11 |
| MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (K954600) | Staar Surgical Co. | 1995-12-21 |