TIER A MODELS 24050,24150,25050,25350-125 LENSES
FDA premarket approval P880082/S012 · decided 1991-09-04
Approval details
- PMA number
- P880082
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TIER A MODELS 24050,24150,25050,25350-125 LENSES
- Generic name
- intraocular lens
- Applicant
- Eyetech, LLC
- Date received
- 1991-05-01
- Decision date
- 1991-09-04
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Oakdale, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EPISCLERAL VENOUS PRESSURE (K843354) | Eyetech, LLC | 1984-11-19 |