MODIFIED J-LOOP POSTERIOR CHAMBER IOL
FDA premarket approval P880072/S036 · decided 1996-02-12
Approval details
- PMA number
- P880072
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODIFIED J-LOOP POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Eyekon Medical, Inc.
- Date received
- 1995-08-25
- Decision date
- 1996-02-12
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
- Statement
- APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |