BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A)
FDA premarket approval P860022/S056 · decided 2006-05-30
Approval details
- PMA number
- P860022
- Supplement
- S056
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A)
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Bausch & Lomb
- Date received
- 2006-01-27
- Decision date
- 2006-05-30
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- 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
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| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
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