|
Device | Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear |
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 | S044 |
Date Received | 08/20/2020 |
Decision Date | 09/16/2020 |
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 a new sterilizer installed at the CooperVision Manufacturing facility in Juana Diaz, Puerto Rico. |