Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
FDA premarket approval P050031/S003 · decided 2019-05-28
Approval details
- PMA number
- P050031
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2019-02-04
- Decision date
- 2019-05-28
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval to change the solution used in wet shipping of the Paragon Z CRT and Paragon Z CRT Dual Axis Contact Lenses from Alcon Laboratories Unique pH Multipurpose Solution to Bausch & Lombs Boston SIMPLUS Multipurpose Solution.
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