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Device | Biomedics 55 Asphere (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 | S049 |
Date Received | 08/29/2022 |
Decision Date | 09/23/2022 |
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 Biomedics 55 Asphere lens capability onto existing manufacturing lines at CooperVision Manufacturing Puerto Rico, LLC. |