VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P820021/S033 · decided 2011-06-08
Approval details
- PMA number
- P820021
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2011-05-09
- Decision date
- 2011-06-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- CHANGE THE ALTERNATE RAW MATERIAL SOURCING FOR (VIFILCON A FORMULATION) SOFT CONTACT LENS MATERIALS.
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