Recor Medical, Inc.: PMA supplement approved for Paradise Ultrasound Renal Denervation System (Paradise System)
Recor Medical, Inc. (Palo Alto, California): PMA supplement approved for Paradise Ultrasound Renal Denervation System (Paradise System). Dated 84 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 109 related CA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Recor Medical, Inc. |
| Product | Paradise Ultrasound Renal Denervation System (Paradise System) |
| Generic / ingredient | Ablation catheter, renal denervation |
| Approval | PMA supplement (device change) |
| Application | P220023 S011 |
| Decided | 2026-08-13 |
| Panel / class | Cardiovascular |
| Sponsor location | Palo Alto, CA |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-13
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (CA first): Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · ABBOTT MEDICAL · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Recor Medical, Inc. and 110 California peers
- California FdaApprovalPulse records like this one: 110
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $22,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Recor Medical, Inc. in Palo Alto, California?
The FDA approved Paradise Ultrasound Renal Denervation System (Paradise System) (P220023 S011) for Recor Medical, Inc. on 2026-08-13: PMA supplement (device change).
How does Recor Medical, Inc. compare to other California FdaApprovalPulse records?
It is 84 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Recor Medical, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Recor Medical, Inc. | Palo Alto, CA | 2026-08-13 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.