VISTAKON (senofilcon A) Multifocal and Multifocal Toric Contact Lenses
FDA premarket approval P040045/S118 · decided 2020-12-03
Approval details
- PMA number
- P040045
- Supplement
- S118
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTAKON (senofilcon A) Multifocal and Multifocal Toric Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2020-09-04
- Decision date
- 2020-12-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Use of alternate multifocal and multifocal toric lens designs and change to the ratio of components in the packaging solution.
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