PMA supplement
P990035 S002: SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
FDA PMA supplement · Normal 180 Day Track · Beam-Med, Ltd.
Key facts
| Original PMA | P990035 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER |
| Generic name | Bone sonometer |
| Applicant | Beam-Med, Ltd. |
| Product code | MUA |
| Received date | Jun 26, 2001 |
| Decision date | Jul 27, 2001 |
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: