VISTAKON (senofilcon A) Brand Contact Lenses
FDA premarket approval P040045/S138 · decided 2024-10-30
Approval details
- PMA number
- P040045
- Supplement
- S138
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (senofilcon A) Brand Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2024-09-30
- Decision date
- 2024-10-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- the addition of an alternate raw material supplier for a processing aid (hydration solvent) used in the manufacturing process of VISTAKON (senofilcon A) Brand Contact Lenses
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