ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
FDA premarket approval N18033/S035 · decided 2001-04-12
Approval details
- PMA number
- N18033
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2001-01-29
- Decision date
- 2001-04-12
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ETAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR WITH UV BLOCKER AND THE FOLLWOING LISTED COLOR ADDITIVES: IRON OXIDE BLACK, IRON OXIDE BROWN, IRON OXIDE RED, IRON OXIDE YELLOW, TITANIUM DIOXIDE, PHTHALOCYANINATO (2-) COPPER, PHTHALOCYANINE GREEN AND VAT ORANGE 1. THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATNIONS: THE ACUVUE (R) 2 COLOURS CONTACT LENSES ARE INDICATED FOR DAILY WEAR TO ENHANCE OR LATER THE APPARENT COLOR OF THE EYE AND/OR FOR
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