PMA
P020049: PROCOL VASCULAR BIOPROSTHESIS
FDA PMA · Tissue graft of 6mm and greater · LeMaitre Vascular, Inc.
Key facts
| PMA number | P020049 |
|---|---|
| Trade name | PROCOL VASCULAR BIOPROSTHESIS |
| Generic name | Tissue graft of 6mm and greater |
| Applicant | LeMaitre Vascular, Inc. |
| Owner/operator | LEMAITRE VASCULAR, INC. |
| Product code | LXA |
| Approval date | Jul 29, 2003 |
| Docket number | 03M-0352 |
| Notice date | Aug 7, 2003 |
| Establishment registration | 1220948 |
| FEI number | 1220948 |
At a glance
- 1–9 Supplements
- Sep 28, 2018 Latest supplement decision
- No Withdrawn
- Yes 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: