PMA supplement
P220023 S011: Paradise™ Ultrasound Renal Denervation System (Paradise System)
FDA PMA supplement · Normal 180 Day Track No User Fee · Recor Medical, Inc.
Key facts
| Original PMA | P220023 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Paradise™ Ultrasound Renal Denervation System (Paradise System) |
| Generic name | Ablation catheter, renal denervation |
| Applicant | Recor Medical, Inc. |
| Product code | QYI |
| Received date | May 19, 2026 |
| Decision date | Aug 13, 2026 |
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: