MODIFIED J & C LOOP MODEL PA36
FDA premarket approval P880072/S026 · decided 1995-07-24
Approval details
- PMA number
- P880072
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODIFIED J & C LOOP MODEL PA36
- Generic name
- intraocular lens
- Applicant
- Eyekon Medical, Inc.
- Date received
- 1995-05-16
- Decision date
- 1995-07-24
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
- Statement
- APPROVAL FOR MODELS GS55A-OUV & GS55B-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS AS TIER A MODIFICATIONS OF MODEL PA90E-2UV AND FOR IMPLANTATION IN THE CAPSULAR BAG ONLY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |