|
Device | OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | THE COOPER COMPANIES 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
PMA Number | P890023 |
Supplement Number | S024 |
Date Received | 12/22/2015 |
Decision Date | 01/11/2016 |
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 RELOCATION OF THE BIOMEDICS TORIC WET CELL, INSTALLATION OF A NEW TC20I UNIT IN THE BIOMEDICS TORIC QA STATION AND A SOFTWARE UPDATE FOR QA FINAL INSPECTION PRIOR TO MEASUREMENT OF TORIC LENSES. |