BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
FDA premarket approval P890023/S007 · decided 1999-05-10
Approval details
- PMA number
- P890023
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1999-04-20
- Decision date
- 1999-05-10
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- 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.
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