VISTAKON (senofilcon A) Brand Contact Lenses
FDA premarket approval P040045/S073 · decided 2017-06-16
Approval details
- PMA number
- P040045
- Supplement
- S073
- 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
- 2017-05-24
- Decision date
- 2017-06-16
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Reduce the process limit for the maximum allowable cumulative sterilization exposure from 3 to 2 full sterilization runs.
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