ACUVUE CONTACT LENS
FDA premarket approval N18033/S112 · decided 2025-12-16
Approval details
- PMA number
- N18033
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACUVUE CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2025-11-21
- Decision date
- 2025-12-16
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- an update to the control plan for material characteristics for the Vistakon (senofilcon A) and (etafilcon A) Brand Contact Lenses
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