PMA P980031S013

Device: INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S013
Product code: LQE
Decision date: 2024-09-09
Classification: Ophthalmic
Generic name: Implant, corneal, refractive
Approval order statement: approval for a manufacturing site located at AJL Ophthalmic, S.A., Ferdinand Zeppelin 1, Parque Tecnologico Alava, 01510 Minano, Araba, Spain, for manufacturing segment components, inspection, cleaning and primary packaging and sterilization of INTACS Corneal Implants

Current openFDA PMA Record#

Device: INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S013
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2024-09-09
Decision code: APPR
Date received: 2023-10-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at AJL Ophthalmic, S.A., Ferdinand Zeppelin 1, Parque Tecnologico Alava, 01510 Minano, Araba, Spain, for manufacturing segment components, inspection, cleaning and primary packaging and sterilization of INTACS Corneal Implants