CIBA VISION LOTRAFILCON B & A SOFT CONTACT LENSES
FDA premarket approval P010019/S010 · decided 2008-08-06
Approval details
- PMA number
- P010019
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CIBA VISION LOTRAFILCON B & A SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2008-07-07
- Decision date
- 2008-08-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- CHANGE IN THE PLASMA TREATMENT PROCESS, USING AN ALTERNATE GAS MIXTURE TO MAINTAIN UNINTERRUPTED STREAM OF PRODUCT INVENTORY.
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