Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac
FDA premarket approval P870024/S055 · decided 2020-08-18
Approval details
- PMA number
- P870024
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-07-23
- Decision date
- 2020-08-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- 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.
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