VISTAKON® (senofilcon A) Brand Contact Lenses
FDA premarket approval P040045/S127 · decided 2022-09-22
Approval details
- PMA number
- P040045
- Supplement
- S127
- 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
- 2022-06-24
- Decision date
- 2022-09-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a change to the material of the lens container closure (foil lidstock) for VISTAKON® (etafilcon A) and (senofilcon A) Brand Contact Lenses.
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