INTACS® Corneal Implants
FDA premarket approval P980031/S014 · decided 2025-05-02
Approval details
- PMA number
- P980031
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS® Corneal Implants
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2024-02-09
- Decision date
- 2025-05-02
- Days to decision
- 448 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- changes to the polishing and cleaning processes; changes to the supplier of Poly(methyl methacrylate) (PMMA) and Tyvek; and changes to the limulus amebocyte lysate (LAL) testing.
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