VIFILCON A SOFT CONTACT LENSES
FDA premarket approval P820021/S034 · decided 2012-07-30
Approval details
- PMA number
- P820021
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIFILCON A SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2012-07-05
- Decision date
- 2012-07-30
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- CHANGE IN RAW MATERIAL TEST METHOD.
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510(k) clearances by this applicant
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