FREQUENCY 55 UV (METHAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P850079/S045 · decided 2009-04-15
Approval details
- PMA number
- P850079
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREQUENCY 55 UV (METHAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2009-03-18
- Decision date
- 2009-04-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF A RAW MATERIAL USE IN THE MANUFACTURING OF METHAFILCON A SOFT CONTACT LENSES.
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