Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin
FDA premarket approval P870024/S059 · decided 2022-06-08
Approval details
- PMA number
- P870024
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2021-12-14
- Decision date
- 2022-06-08
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the promotion of 3% hydrogen peroxide cleaning and disinfection solution for the disinfection of Paragon CRT family of rigid gas permeable contact lenses (Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tints).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.