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Device | BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(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 | S007 |
Date Received | 04/20/1999 |
Decision Date | 05/10/1999 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a ultraviolet blocker into the matrix of the Biomedics 55 (ocufilcon D) soft (hydrophilic) lens for extended wear, a change in the indications statement to add the sentence "Biomedics UV Blocking Contact Lenses help protect against transmission of harmful UV radiation ot the cornea and in the eye;" and a modified Warning and Note. |