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Device | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 N. GOODMAN ST. ROCHESTER, NY 14692 |
PMA Number | P860022 |
Supplement Number | S055 |
Date Received | 10/28/2003 |
Decision Date | 11/25/2003 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |