VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P820021/S031 · decided 2006-09-20
Approval details
- PMA number
- P820021
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2006-08-22
- Decision date
- 2006-09-20
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR REVISED STABILITY PROTOCOLS.
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