|
Device | ocufilcon D Soft (Hydrophilic) Extended Wear 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 | S031 |
Date Received | 03/16/2018 |
Decision Date | 10/02/2018 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the introduction and validation of a new laboratory sterilizer at CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico. |