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Device | BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P960022 |
Supplement Number | S007 |
Date Received | 11/15/2010 |
Decision Date | 02/18/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NAME CHANGE TO THE CURRENTLY MARKETED BAUSCH & LOMB SOFLENS 66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES. THE PROPOSED NAME FOR THE DEVICE IS BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES. |