NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P820021/S025 · decided 1995-12-13
Approval details
- PMA number
- P820021
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1995-01-17
- Decision date
- 1995-12-13
- Days to decision
- 330 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE LENS BLANKS FOR NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES MANUFACTURED AT CIBA VISION CORORATION, 2910 AMWILER COURT, ATLANTA, BA TO BE FINAL CURED, WET PROCESSED, TINTED, PACKGED, AND STERILIZAED AT THE ALTERNATE MANUFACTURING SITE, CIBA VISION BATAM, BATAM INDUSTRIAL PARK, LOT #204, MUKA KUNING 29433, BATAM ISLAND, INDONESIA
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