ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
FDA premarket approval N18033/S029 · decided 1996-10-07
Approval details
- PMA number
- N18033
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 1996-07-18
- Decision date
- 1996-10-07
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- ADDITION OF A UV BLOCKER, NORBLOC(R) 7966, TO THE APPROVED MOLDED ETAFILCON A EXTENDED WEAR CONTACT LENS (CLEAR AND WITH VISIBILITY TINT), AND A MULTI-FOCAL DESIGN WHICH WAS REVIOUSLY CLEARED FOR THE DAILY WEAR ETAFILCON A LENS UNDER K953804
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