methafilcon A and methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P850079/S077 · decided 2018-11-23
Approval details
- PMA number
- P850079
- Supplement
- S077
- Supplement type
- 135 Review Track For 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
- 2018-01-16
- Decision date
- 2018-11-23
- Days to decision
- 311 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for the harmonization of calibration procedures.
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