|
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 | S082 |
Date Received | 08/16/2017 |
Decision Date | 09/13/2017 |
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 supplier source for the VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses. |