PMA supplement
P840063 S001: GYROSCAN(TM)
FDA PMA supplement · Normal 180 Day Track · Philips Medical Systems, Inc.
Key facts
| Original PMA | P840063 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | GYROSCAN(TM) |
| Generic name | System, nuclear magnetic resonance imaging |
| Applicant | Philips Medical Systems, Inc. |
| Product code | LNH |
| Received date | Oct 16, 1986 |
| Decision date | Mar 3, 1987 |
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: