|
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 | S091 |
Date Received | 11/29/2017 |
Decision Date | 12/19/2017 |
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 Addition of an alternate in-process test method used in the manufacture of VISTAKON (senofilcon A) Brand Contact Lenses. The test method is specific to the presbyopia designs of senofilcon A contact lenses. |