VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
FDA premarket approval P040045/S041 · decided 2014-01-16
Approval details
- PMA number
- P040045
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2013-11-18
- Decision date
- 2014-01-16
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A CHANGE IN THE VISCOSITY SPECIFICATION FROM 120-170 CPS TO100-170 CPS FOR THE REACTIVE MONOMER MIX.
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