VISTAKON (SENOFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER
FDA premarket approval P040045/S014 · decided 2010-11-18
Approval details
- PMA number
- P040045
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (SENOFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2010-06-28
- Decision date
- 2010-11-18
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATE METHOD FOR VISUAL INSPECTION OF RAW MATERIALS FOR VISTAKON® (SENOFILCONA) CONTACT LENSES, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER.
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