Lotrafilcon A and B Soft Contact Lenses for Extended Wear
FDA premarket approval P010019/S072 · decided 2019-11-27
Approval details
- PMA number
- P010019
- Supplement
- S072
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lotrafilcon A and B Soft Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2019-04-03
- Decision date
- 2019-11-27
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for a repackaging site located at Harleigh (Malaysia) SDN. BHD., No. 4, Jalan Tahana, Tampoi Industrial Estate, Johor Bahru, Johor, Malaysia 80350.
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