ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS
FDA premarket approval N18033/S034 · decided 2001-05-18
Approval details
- PMA number
- N18033
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2000-11-03
- Decision date
- 2001-05-18
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR ADDING THE MANUFACTURING FACILITY AT VISTAKON, JOHNSON & JOHNSON (IRELAND) LTE., LIMERICK, IRELAND, FOR THE MANUFACTURE OF ACCUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENSES.
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