FREQUENCY 55/58 UV/XCEL/EXPRESSIONS COLORS/ACCENTS/HYDRASOFT (METHAFILCON A & METHAFILCON B) SOFT (HYDROPHILIC) CONTACT
FDA premarket approval P850079/S051 · decided 2011-11-29
Approval details
- PMA number
- P850079
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREQUENCY 55/58 UV/XCEL/EXPRESSIONS COLORS/ACCENTS/HYDRASOFT (METHAFILCON A & METHAFILCON B) SOFT (HYDROPHILIC) CONTACT
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2011-11-01
- Decision date
- 2011-11-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- CHANGE IN THE STABILITY OF SHELF LIFE PROTOCOL.
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