PMA supplement
P000009 S130: PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T
FDA PMA supplement · Real-Time Process · Biotronik, Inc.
Key facts
| Original PMA | P000009 |
|---|---|
| Supplement number | S130 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | Biotronik, Inc. |
| Product code | MRM |
| Received date | Apr 15, 2026 |
| Decision date | Sep 17, 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: