- Device
- Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints
- Applicant
- CooperVision, Inc.
- PMA number
- P870024
- Supplement
- S054
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2020-08-13
- Decision code
- OK30
- Date received
- 2020-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new computer numeric control (CNC) lathe process used for contact lens manufacturing.