METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
FDA premarket approval P850079/S073 · decided 2017-02-28
Approval details
- PMA number
- P850079
- Supplement
- S073
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-01-30
- Decision date
- 2017-02-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Alternate Packaging and Labeling Site at the West Henrietta, New York Facility.
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