PMA
P870021: PRIME{TM} MODEL 6520, 6525, 6530 AND 6535
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Medtronic, Inc.
Key facts
| PMA number | P870021 |
|---|---|
| Trade name | PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LOX |
| Approval date | Feb 29, 1988 |
| Docket number | 88M-0106 |
| Notice date | May 11, 1988 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 1–9 Supplements
- Oct 4, 1990 Latest supplement decision
- No Withdrawn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: