MODIFIED J & C LOOP MODEL PA36
FDA premarket approval P880072/S030 · decided 1995-08-24
Approval details
- PMA number
- P880072
- Supplement
- S030
- 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
- 1995-05-26
- Decision date
- 1995-08-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
- Statement
- RESPONSE TO FDA'S LETTER OF APRIL 28, 1995, RE:YOUR 1992 AND 1993 ANNUAL REPORTS & REQUESTED TIER A APPROVAL FOR MDLS:GL55A-OUV, GL55B-OUV,PS40D-OUV,PS60C-OUV,PB61B-OUV,PB07C-OUV & LP57L-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS
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 |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |