PMA P860022S059
- Device
- BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S059
- Product code
- MWL
- Decision date
- 2016-07-25
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Approval order statement
- Alternate supplier of a critical raw material component.
Current openFDA PMA Record#
- Device
- BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S059
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2016-07-25
- Decision code
- OK30
- Date received
- 2016-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of a critical raw material component.