PMA P050031S003
- Device
- Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P050031
- Supplement
- S003
- Product code
- NUU
- Decision date
- 2019-05-28
- Classification
- Lens, Contact, Orthokeratology, Overnight
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order 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.
Current openFDA PMA Record#
- Device
- Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses
- Applicant
- CooperVision, Inc.
- PMA number
- P050031
- Supplement
- S003
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2019-05-28
- Decision code
- APPR
- Date received
- 2019-02-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.