FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
FDA premarket approval P820021/S029 · decided 1996-09-25
Approval details
- PMA number
- P820021
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1996-05-10
- Decision date
- 1996-09-25
- Days to decision
- 138 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR REVISED LABELING (I.E., PACKAGE INSERT, PRACTITIONER FITTING GUIDE, AND SEPARATE PATIENT INFORMATION BOOKLETS FOR LENSES PRESCRIBED FOR FREQUENT REPLACEMENT WEAR (FOCUS, FOCUS TORIC, AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES) AND DISPOSABLE WEAR (NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES). REVISIONS INCLUDED (1)MERGING PLANNED REPLACEMENT AND DISPOSABLE WEARING SCHEDULES FOR THE LENSESE INTO ONE PACKAGE INSERT AND DIRECTING THE PACKAGE ISERT TO THE EYEC
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510(k) clearances by this applicant
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