VISTAKON (senofilcon A) Brand Contact Lenses
FDA premarket approval P040045/S117 · decided 2021-12-23
Approval details
- PMA number
- P040045
- Supplement
- S117
- Supplement type
- 135 Review Track For 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
- 2020-08-18
- Decision date
- 2021-12-23
- Days to decision
- 492 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for the implementation of an alternate qualified supplier for one raw material used in the senofilcon A packaging solution and as a processing aid during the post hydration process for VISTAKON® (senofilcon A) Brand Contact Lenses.
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