VISTAKON (SENOFILCON A) BRANDED CONTACT LENSES.
FDA premarket approval P040045/S064 · decided 2017-01-12
Approval details
- PMA number
- P040045
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (SENOFILCON A) BRANDED CONTACT LENSES.
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2016-12-20
- Decision date
- 2017-01-12
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Acceptance for a modification to the raw material testing for VISTAKON® (senofilcon A) and VISTAKON® (etafilcon A) Brand Contact Lenses.
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