ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
FDA premarket approval N18033/S031 · decided 1997-07-11
Approval details
- PMA number
- N18033
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 1997-07-03
- Decision date
- 1997-07-11
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for changes in the Package Insert and Fitting and Patient Management Guide pertaining to the ACUVUE(R) BIFOCAL (etafilcon A) Contact Lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made tot he remaining portions of approved labeling.
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