OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
FDA premarket approval P890023/S004 · decided 1996-08-28
Approval details
- PMA number
- P890023
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1995-10-02
- Decision date
- 1996-08-28
- Days to decision
- 331 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN
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