|
Device | HYDROCURVE (BUFILCON A CONTACT LENSES) |
Generic Name | Lenses, soft contact, daily wear |
Regulation Number | 886.5925 |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 |
PMA Number | N17752 |
Supplement Number | S036 |
Date Received | 05/15/1995 |
Decision Date | 09/22/1995 |
Withdrawal Date
|
06/05/2013 |
Product Code |
LPL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES AS REFERENCED ABOVE |