- Device
- BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A)
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S056
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2006-05-30
- Decision code
- APPR
- Date received
- 2006-01-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS