Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
FDA premarket approval P050031/S007 · decided 2020-08-31
Approval details
- PMA number
- P050031
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2020-08-05
- Decision date
- 2020-08-31
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of a new laser machine to engrave the lenses.
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