ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM
FDA premarket approval P900048/S001 · decided 1992-03-05
Approval details
- PMA number
- P900048
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM
- Generic name
- intraocular lens
- Applicant
- Staar Surgical Co.
- Date received
- 1991-03-06
- Decision date
- 1992-03-05
- Days to decision
- 365 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
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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 |