VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P040045/S003 · decided 2008-01-18
Approval details
- PMA number
- P040045
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2007-11-20
- Decision date
- 2008-01-18
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR MINOR LABELING CHANGES.
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