VISTAKON (SENOFILCON A) BAND CONTACT LENS,
FDA premarket approval P040045/S060 · decided 2016-10-27
Approval details
- PMA number
- P040045
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (SENOFILCON A) BAND CONTACT LENS,
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2016-09-30
- Decision date
- 2016-10-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Introduce a new injection molding machine (IMM), Sumitomo dual IMM, to produce front curve and back curve molds for VISTAKON® (senofilcon A) Brand Contact Lenses.
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