- Device
- Frequency Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf
- Applicant
- CooperVision, Inc.
- PMA number
- P850079
- Supplement
- S076
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2017-11-22
- Decision code
- OK30
- Date received
- 2017-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a new Rapid Readout Biological Indicators (RRBIs) incubator and the reduction in the number of RRBIs.