PMA P890023S022

Device: EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S022
Product code: LPM
Decision date: 2014-11-21
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR THE ADDITION OF THE NEW PRIVATE LABEL BRAND NAME EQUATE ASPHERE AND EQUATE TORIC TO THE DEVICE LABELING.

Current openFDA PMA Record#

Device: EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S022
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2014-11-21
Decision code: APPR
Date received: 2014-09-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE NEW PRIVATE LABEL BRAND NAME EQUATE ASPHERE AND EQUATE TORIC TO THE DEVICE LABELING.