UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
FDA premarket approval P880091/S011 · decided 1998-07-20
Approval details
- PMA number
- P880091
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
- Generic name
- intraocular lens
- Applicant
- Staar Surgical Co.
- Date received
- 1997-08-14
- Decision date
- 1998-07-20
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval to package the MicroSTAAR injector cartridges with the ELASTIMIDE(TM) lenses, and for a five-year shelf life for the cartridges sterilized via your new ethylene oxide (EtO) cycle.
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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 |