PMA supplement
P080011 S144: Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters
FDA PMA supplement · Normal 180 Day Track No User Fee · CooperVision, Inc.
Key facts
| Original PMA | P080011 |
|---|---|
| Supplement number | S144 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | CooperVision, Inc. |
| Product code | LPM |
| Received date | Apr 1, 2022 |
| Decision date | Aug 15, 2022 |
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: