PMA supplement
P970040 S003: ACHILLES EXPRESS ULTRASONOMETER
FDA PMA supplement · Normal 180 Day Track No User Fee · Ge Lunar Corp.
Key facts
| Original PMA | P970040 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Express GMP Supplement |
| Trade name | ACHILLES EXPRESS ULTRASONOMETER |
| Generic name | Bone sonometer |
| Applicant | Ge Lunar Corp. |
| Product code | MUA |
| Received date | Jul 15, 2004 |
| Decision date | Jul 30, 2004 |
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: