PMA supplement
P850051 S080: ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P850051 |
|---|---|
| Supplement number | S080 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Medtronic, Inc. |
| Product code | LWP |
| Received date | Apr 18, 2013 |
| Decision date | Jun 11, 2013 |
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: