PMA
P210039: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
FDA PMA · Drug-Eluting Peripheral Transluminal Angioplasty Catheter · Trireme Medical, LLC
Key facts
| PMA number | P210039 |
|---|---|
| Trade name | Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Trireme Medical, LLC |
| Product code | ONU |
| Approval date | Nov 4, 2022 |
| Docket number | 22M-2824 |
| Notice date | Nov 18, 2022 |
| FEI number | 3008089360 |
At a glance
- 1–9 Supplements
- Aug 16, 2023 Latest supplement decision
- No Withdrawn
- Yes 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: