STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR
FDA premarket approval P880091/S029 · decided 2009-01-09
Approval details
- PMA number
- P880091
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR
- Generic name
- intraocular lens
- Applicant
- Staar Surgical Co.
- Date received
- 2008-12-12
- Decision date
- 2009-01-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- REPLACEMENT OF THE CURRENT FILTER USED DURING THE FILTERING PROCESS OF THE RMX-3 SILICONE BASE MATERIAL.
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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 |