Mainstay Medical Limited: PMA supplement approved for ReActiv8 Implantable Neurostimulation System
Mainstay Medical Limited (Swords, Co Dublin): PMA supplement approved for ReActiv8 Implantable Neurostimulation System. Dated 16 days ago, it is in the active follow-up window. Score 60/100. 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 | Mainstay Medical Limited |
| Product | ReActiv8 Implantable Neurostimulation System |
| Generic / ingredient | Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief |
| Approval | PMA supplement (device change) |
| Application | P190021 S012 |
| Decided | 2026-10-19 |
| Panel / class | Neurology |
| Sponsor location | Swords, Co Dublin |
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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: 2026-10-19
- 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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60 / 100 Score
- Decided in the last 30 days.
What is the FdaApprovalPulse record for Mainstay Medical Limited in Swords, Co Dublin?
The FDA approved ReActiv8 Implantable Neurostimulation System (P190021 S012) for Mainstay Medical Limited on 2026-10-19: PMA supplement (device change).
How does Mainstay Medical Limited compare to other FdaApprovalPulse records?
It is 16 days old, still within a typical 45-day follow-up window.
Mainstay Medical Limited vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Mainstay Medical Limited | Swords, Co Dublin | 2026-10-19 |
| 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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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.