PMA P890023S007

Device: BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S007
Product code: LPM
Decision date: 1999-05-10
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
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.

Current openFDA PMA Record#

Device: BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S007
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1999-05-10
Decision code: APPR
Date received: 1999-04-20
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.