|
Device | Lotrafilcon A Soft Contact Lenses and Lotrafilcon 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 | S076 |
Date Received | 02/18/2020 |
Decision Date | 03/19/2020 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternate polypropylene resin and supplier used in the blister shells for primary packaging of lotrafilcon A and B extended wear soft contact lenses. |