Lotrafilcon A Soft Contact Lenses for Extended Wear
FDA premarket approval P010019/S063 · decided 2018-03-02
Approval details
- PMA number
- P010019
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lotrafilcon A Soft Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2018-02-02
- Decision date
- 2018-03-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Startup of lotrafilcon A back end finishing production at the Johor, Malaysia facility including technology transfer from the Batam Indonesia manufacturing facility to the production facility in Johor, Malaysia.
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