|
Device | BAUSCH & LOMB SOFLENS 38 (POLYMACON) 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 | N16895 |
Supplement Number | S094 |
Date Received | 10/19/2011 |
Decision Date | 05/02/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE RAW MATERIAL HYDROXYETHYL-METHYL-METHACRYLATE FOR POLYMACON AND ALPHAFILCON A SOFT CONTACT LENSES. |