PMA supplement
P910031 S017: GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
FDA PMA supplement · Real-Time Process · Abbott Vascular Devices
Key facts
| Original PMA | P910031 |
|---|---|
| Supplement number | S017 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular Devices |
| Product code | LOX |
| Received date | Oct 14, 1997 |
| Decision date | Nov 10, 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: