|
Device | LOTRAFILCON SOFT CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P010019 |
Supplement Number | S007 |
Date Received | 09/14/2007 |
Decision Date | 02/08/2008 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT CIBA VISION JOHOR SDN. BHD., JOHOR MALAYSIA, FOR THE FINISHING (BACK-END MANUFACTURING) OF THE DEVICE. |