PMA supplement
P190008 S028: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Vascular, Inc.
Key facts
| Original PMA | P190008 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon |
| Generic name | Drug-coated peripheral transluminal angioplasty catheter |
| Applicant | Medtronic Vascular, Inc. |
| Product code | PRC |
| Received date | Oct 26, 2023 |
| Decision date | Apr 23, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: