PMA supplement
P890001 S014: LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
FDA PMA supplement · THIRTY DAY TRACK · Leocor, Inc.
Key facts
| Original PMA | P890001 |
|---|---|
| Supplement number | S014 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Leocor, Inc. |
| Product code | LOX |
| Received date | Jun 21, 1995 |
| Decision date | Jun 13, 1996 |
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: