FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
FDA premarket approval P010019/S048 · decided 2016-03-23
Approval details
- PMA number
- P010019
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2016-03-01
- Decision date
- 2016-03-23
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Installation and qualification of a new water pre-treatment and a new USP purified water system used in the production of USP purified water at the Batam, Indonesia manufacturing site.
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