Saluda Medical Pty, Ltd.: PMA supplement approved for CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application
Saluda Medical Pty, Ltd. (Atarmon): PMA supplement approved for CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application. Dated 128 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: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Saluda Medical Pty, Ltd. |
| Product | CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer |
| Generic / ingredient | Stimulator, spinal-cord, totally implanted for pain relief |
| Approval | PMA supplement (device change) |
| Application | P190002 S039 |
| Decided | 2026-06-29 |
| Panel / class | Neurology |
| Sponsor location | Atarmon |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-06-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records: Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Advanced Medical Solutions Limited · Lenstec, Inc. · 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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30 / 100 Score
What is the FdaApprovalPulse record for Saluda Medical Pty, Ltd. in Atarmon?
The FDA approved CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer (P190002 S039) for Saluda Medical Pty, Ltd. on 2026-06-29: PMA supplement (device change).
How does Saluda Medical Pty, Ltd. compare to other FdaApprovalPulse records?
It is 128 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.
Saluda Medical Pty, Ltd. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Saluda Medical Pty, Ltd. | Atarmon | 2026-06-29 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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.