|
Device | LOTRAFILCON A & B 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 | S053 |
Date Received | 01/23/2017 |
Decision Date | 10/17/2017 |
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 elimination of duplicate, redundant in process QC testing of raw materials used in the production of Alcon lotrafilcon A and B soft contact lens products for daily and extended wear. |