TIER A MODELS 24050,24150,25050,25350-125 LENSES
FDA premarket approval P880082/S013 · decided 1991-08-06
Approval details
- PMA number
- P880082
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TIER A MODELS 24050,24150,25050,25350-125 LENSES
- Generic name
- intraocular lens
- Applicant
- Eyetech, LLC
- Date received
- 1991-05-24
- Decision date
- 1991-08-06
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Oakdale, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EPISCLERAL VENOUS PRESSURE (K843354) | Eyetech, LLC | 1984-11-19 |