- Device
- Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S068
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-04-25
- Decision code
- APPR
- Date received
- 2018-01-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approved for the addition of a new private label brand name Sofmed breathables XW (comfilcon A), Sofmed breathables XW premium (comfilcon A), Sofmed breathables XW toric (comfilcon A) and Sofmed breathables XW multifocal (comfilcon A) Soft Extended Wear Contact Lenses.