|
Device | BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT 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 | S008 |
Date Received | 03/03/2011 |
Decision Date | 03/28/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE WITH THE SUPPLIER OF THE RAW MATERIAL PROCESSING FOR THE SOFLENS66 AND SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES. |