Paragon Z CRT, Paragon Z CRT Dual Axis
FDA premarket approval P050031/S009 · decided 2022-05-10
Approval details
- PMA number
- P050031
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon Z CRT, Paragon Z CRT Dual Axis
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2022-04-15
- Decision date
- 2022-05-10
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of a new power reader in the manufacturing process, the establishment of a fourth manufacturing line and a change in the blocking process for lens lathing.
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