PMA supplement
P080011 S068: Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal
FDA PMA supplement · Normal 180 Day Track No User Fee · CooperVision, Inc.
Key facts
| Original PMA | P080011 |
|---|---|
| Supplement number | S068 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | CooperVision, Inc. |
| Product code | LPM |
| Received date | Jan 11, 2018 |
| Decision date | Apr 25, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: