PMA supplement
P890003 S284: REVEAL DX, REVEAL XT
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P890003 |
|---|---|
| Supplement number | S284 |
| Supplement type | Real-Time Process |
| Trade name | REVEAL DX, REVEAL XT |
| Generic name | Pacemaker/icd/crt non-implanted components |
| Applicant | Medtronic, Inc. |
| Product code | OSR |
| Received date | Aug 12, 2013 |
| Decision date | Oct 15, 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: