PMA
P190008: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
FDA PMA · Drug-coated peripheral transluminal angioplasty catheter · Medtronic Vascular, Inc.
Key facts
| PMA number | P190008 |
|---|---|
| Trade name | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
| Generic name | Drug-coated peripheral transluminal angioplasty catheter |
| Applicant | Medtronic Vascular, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | PRC |
| Approval date | Nov 21, 2019 |
| Docket number | 19M-5534 |
| Notice date | Nov 22, 2019 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- May 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: