PMA supplement
P870024 S060: FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
FDA PMA supplement · Normal 180 Day Track No User Fee · CooperVision, Inc.
Key facts
| Original PMA | P870024 |
|---|---|
| Supplement number | S060 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | CooperVision, Inc. |
| Product code | MWL |
| Received date | Mar 21, 2022 |
| Decision date | Jun 16, 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: