PMA supplement
P860062 S001: RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST
FDA PMA supplement · THIRTY DAY TRACK · Resonex, Inc.
Key facts
| Original PMA | P860062 |
|---|---|
| Supplement number | S001 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST |
| Generic name | System, nuclear magnetic resonance imaging |
| Applicant | Resonex, Inc. |
| Product code | LNH |
| Received date | Apr 11, 1988 |
| Decision date | May 25, 1988 |
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: