|
Device | VISTAKON (SENOFILCON A) BRAND CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR 7500 CENTURION PARKWAY SUITE 100 - ERCA JACKSONVILLE, FL 32256 |
PMA Number | P040045 |
Supplement Number | S053 |
Date Received | 11/25/2015 |
Decision Date | 12/10/2015 |
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 IMPLEMENTATION OF AN ALTERNATE RAW MATERIAL PROCESS FOR A SENOFILCON A MONOMER COMPONENTS OF VISTAKON (SENOFILCON A) BRAND CONTACT LENSES. |