ACUVUE (ETAFILCON A) CONTACT LENS
FDA premarket approval N18033/S033 · decided 1999-05-05
Approval details
- PMA number
- N18033
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACUVUE (ETAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 1999-04-01
- Decision date
- 1999-05-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a change in the indications statement to add the sentence "ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye;" and modified Note and Warning.
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