ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
FDA premarket approval N18033/S030 · decided 1997-05-14
Approval details
- PMA number
- N18033
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 1997-05-02
- Decision date
- 1997-05-14
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL TO MAKE A MINOR CHANGE IN THE INITIATOR RATIO (INCREASED AMOUNT) FOR THE ACUVUE(R) (ETAFILCON A) CONTACT LENS, WHICH WAS APPROVED AS N18-033/S29 ON OCTOBER 7, 1996. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE CURRENT TRADE NAME WITH NO CHANGE TO THE INDICATIONS FOR USE OR THE ESTABLISHED SHELF-LIFE.
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