|
Device | AIR OPTIX FOR ASTIGMATISM |
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 | S011 |
Date Received | 08/25/2008 |
Decision Date | 01/16/2009 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AIR OPTIX FOR ASTIGMATISM (LOTRAFILCON B) SOFT CONTACT LENSES. |