VISTAKON (senofilcon A) Brand Contact Lenses
FDA premarket approval P040045/S139 · decided 2025-02-05
Approval details
- PMA number
- P040045
- Supplement
- S139
- 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
- 2025-01-13
- Decision date
- 2025-02-05
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- qualification of an additional production line at the manufacturing facility located in Limerick, Ireland and recartoning of individual primary packages into the final unit of sale at an existing external vendor
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