PMA supplement
P910031 S019: THE ORACLE MEGASONICS FIVE-64 PTCA CATHER
FDA PMA supplement · Normal 180 Day Track · Abbott Vascular Devices
Key facts
| Original PMA | P910031 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | THE ORACLE MEGASONICS FIVE-64 PTCA CATHER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular Devices |
| Product code | LOX |
| Received date | Jun 15, 1998 |
| Decision date | Dec 11, 1998 |
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: