BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P860022/S055 · decided 2003-11-25
Approval details
- PMA number
- P860022
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Bausch & Lomb
- Date received
- 2003-10-28
- Decision date
- 2003-11-25
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR COMBINING THE DAILY WEAR AND EXTENDED WEAR LABELING OF THE DEVICE TO BRING THE EXTENDED WEAR LABELING INTO ALIGNMENT WITH THE DAILY WEAR LABELING.
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