PMA P870024S062

Device: Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an
Applicant: CooperVision, Inc.
PMA number: P870024
Supplement: S062
Product code: MWL
Decision date: 2022-05-10
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order statement: Addition of a new power reader in the manufacturing process, the establishment of a fourth manufacturing line and a change in the blocking process for lens lathing.

Current openFDA PMA Record#

Device: Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an
Applicant: CooperVision, Inc.
PMA number: P870024
Supplement: S062
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2022-05-10
Decision code: OK30
Date received: 2022-04-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new power reader in the manufacturing process, the establishment of a fourth manufacturing line and a change in the blocking process for lens lathing.