PMA
P850021: AMER, ED. LABS. PTCA
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Abbott Vascular, Inc.
Key facts
| PMA number | P850021 |
|---|---|
| Trade name | AMER, ED. LABS. PTCA |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOX |
| Approval date | May 30, 1986 |
| Docket number | 86M-0259 |
| Notice date | Jul 9, 1986 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Nov 27, 1995 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: