VISTAKON SENOFILCON A CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P040045/S002 · decided 2008-03-31
Approval details
- PMA number
- P040045
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON SENOFILCON A CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2007-10-23
- Decision date
- 2008-03-31
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT JOHNSON & JOHNSON (IRELAND) LTD., LIMERICK, IRELAND.
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