PMA P980031S014

Device: INTACS® Corneal Implants
Applicant: Addition Technology
PMA number: P980031
Supplement: S014
Product code: LQE
Decision date: 2025-05-02
Classification: Ophthalmic
Generic name: Implant, corneal, refractive
Approval order 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.

Current openFDA PMA Record#

Device: INTACS® Corneal Implants
Applicant: Addition Technology
PMA number: P980031
Supplement: S014
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2025-05-02
Decision code: APPR
Date received: 2024-02-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.