PMA supplement
P870036 S042: MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
FDA PMA supplement · Medtronics Interventional Vascular
Key facts
| Original PMA | P870036 |
|---|---|
| Supplement number | S042 |
| Trade name | MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronics Interventional Vascular |
| Product code | LOX |
| Received date | Jan 29, 1997 |
| Decision date | Jul 28, 1997 |
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: