FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
FDA premarket approval P820021/S028 · decided 1996-03-18
Approval details
- PMA number
- P820021
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1995-06-27
- Decision date
- 1996-03-18
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN AUTOMATED MANUFACTURING LINE AND PROCESS FOR FOCUS AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC( CONTACT LENSES
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