H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P890023/S005 · decided 1997-05-06
Approval details
- PMA number
- P890023
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1995-10-23
- Decision date
- 1997-05-06
- Days to decision
- 561 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- 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.
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