PMA P860022S057
- Device
- BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S057
- Product code
- MWL
- Decision date
- 2008-02-21
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Approval order statement
- APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.
Current openFDA PMA Record#
- Device
- BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S057
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2008-02-21
- Decision code
- APPR
- Date received
- 2008-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.