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Device | Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft 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 | S040 |
Date Received | 12/03/2019 |
Decision Date | 12/18/2019 |
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 the manufacture of Biomedics 55 Asphere with a base curve of 8.9 mm in the Scottsville facility. |