VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
FDA premarket approval N18033/S061 · decided 2012-02-01
Approval details
- PMA number
- N18033
- Supplement
- S061
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2011-09-19
- Decision date
- 2012-02-01
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY OF THE RAW MATERIALS USED IN REACTIVE MONOMER MIX FORMULATION.
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