PMA P050031

Device: Paragon Z CRT, Paragon Z CRT Dual Axis
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S009
Product code: NUU
Decision date: 2022-05-10
Generic name: Lens, contact, orthokeratology, overnight
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 Z CRT, Paragon Z CRT Dual Axis
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S009
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
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.