PMA P870024S059

Device: Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin
Applicant: CooperVision, Inc.
Product code: MWL
Decision date: 2022-06-08
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order statement: Approval for the promotion of 3% hydrogen peroxide cleaning and disinfection solution for the disinfection of Paragon CRT family of rigid gas permeable contact lenses (Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tints).

Current openFDA PMA Record#

Device: Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin
Applicant: CooperVision, Inc.
PMA number: P870024
Supplement: S059
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2022-06-08
Decision code: APPR
Date received: 2021-12-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the promotion of 3% hydrogen peroxide cleaning and disinfection solution for the disinfection of Paragon CRT family of rigid gas permeable contact lenses (Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tints).