PMA P050031S007
- Device
- Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
- Applicant
- CooperVision, Inc.
- PMA number
- P050031
- Supplement
- S007
- Product code
- NUU
- Decision date
- 2020-08-31
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- Addition of a new laser machine to engrave the lenses.
Current openFDA PMA Record#
- Device
- Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
- Applicant
- CooperVision, Inc.
- PMA number
- P050031
- Supplement
- S007
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2020-08-31
- Decision code
- OK30
- Date received
- 2020-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new laser machine to engrave the lenses.