VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL
FDA premarket approval P040045/S001 · decided 2007-08-14
Approval details
- PMA number
- P040045
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2007-04-23
- Decision date
- 2007-08-14
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ADDITIONAL INDICATION FOR THERAPEUTIC USE FOR THE VISTAKON (SENOFILCON A) CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACUVUE OASYS BRAND CONTACT LENSES WITH HYDRACLEAR PLUS (SENOFILCON A) AND IS ADDITIONALLY INDICATED FOR THERAPEUTIC USE AS A BANDAGE LENS FOR THE FOLLOWING ACUTE AND CHRONIC CONDITIONS:1) FOR CORNEAL PROTECTION IN LID AND CORNEAL ABNORMALITIES SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS AND RECURRENT CORNEAL EROSION. IN ADDITION IT
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