PMA supplement
P870036 S035: MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER
FDA PMA supplement · THIRTY DAY TRACK · Medtronics Interventional Vascular
Key facts
| Original PMA | P870036 |
|---|---|
| Supplement number | S035 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronics Interventional Vascular |
| Product code | LOX |
| Received date | Apr 7, 1995 |
| Decision date | Apr 27, 1995 |
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: