|
Device | CIBA VISION (VASURFILCON A) 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 | P940013 |
Supplement Number | S010 |
Date Received | 02/24/2010 |
Decision Date | 04/13/2010 |
Withdrawal Date
|
12/15/2014 |
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 P.T. CIBA VISION BATAM, BATAM ISLAND, INDONESIA FOR FRONT-END PROCESSING OF THE DEVICE. |