PMA
P220023: Paradise® Ultrasound Renal Denervation System
FDA PMA · Ablation catheter, renal denervation · Recor Medical, Inc.
Key facts
| PMA number | P220023 |
|---|---|
| Trade name | Paradise® Ultrasound Renal Denervation System |
| Generic name | Ablation catheter, renal denervation |
| Applicant | Recor Medical, Inc. |
| Owner/operator | Recor Medical, Inc. |
| Product code | QYI |
| Approval date | Nov 7, 2023 |
| Docket number | 23M-4937 |
| Notice date | Nov 16, 2023 |
| Establishment registration | 3010024164 |
| FEI number | 3010024164 |
At a glance
- 10–99 Supplements
- Aug 13, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: