PMA
P960014: MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Global Therapeutics, Inc.
Key facts
| PMA number | P960014 |
|---|---|
| Trade name | MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Global Therapeutics, Inc. |
| Product code | LOX |
| Approval date | Oct 5, 1998 |
| Docket number | 98M-0897 |
| Notice date | Nov 18, 1998 |
At a glance
- None Supplements
- Oct 5, 1998 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: