PMA P890023S005

Device: H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S005
Product code: LPM
Decision date: 1997-05-06
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR THE CAST MOLDING METHOD FOR THE MANUFACTURE OF THE OCUFILCON D 55% HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR AT THE COMPANY'S FACILITY LOCATED AT SANT ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757.

Current openFDA PMA Record#

Device: H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S005
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1997-05-06
Decision code: APPR
Date received: 1995-10-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CAST MOLDING METHOD FOR THE MANUFACTURE OF THE OCUFILCON D 55% HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR AT THE COMPANY'S FACILITY LOCATED AT SANT ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757.