- Device
- Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac
- Applicant
- CooperVision, Inc.
- PMA number
- P870024
- Supplement
- S055
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2020-08-18
- Decision code
- OK30
- Date received
- 2020-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of a second supplier of a raw material monomer used in the manufacture of Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), and Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable (RGP) Contact Lenses.