VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER
FDA premarket approval N18033/S042 · decided 2010-02-19
Approval details
- PMA number
- N18033
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2009-06-22
- Decision date
- 2010-02-19
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE.
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