Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin
FDA premarket approval P870024/S053 · decided 2020-04-20
Approval details
- PMA number
- P870024
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2020-03-26
- Decision date
- 2020-04-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Software update for generating lathe cutting files for Paragon CRT®100 (paflufocon D) and Paragon CRT Dual Axis® (paflufocon D) Rigid Gas Permeable contact lenses in clear and tints.
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