Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P850079/S086 · decided 2020-03-12
Approval details
- PMA number
- P850079
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-02-13
- Decision date
- 2020-03-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Introduction of a new Total Organic Carbon (TOC) analyzer for the testing of purified water supplies at the CooperVision Manufacturing, Ltd. facilities located in Hamble, UK and Chandlers Ford, UK.
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