PMA
P190020: BioFreedom Drug Coated Coronary Stent System
FDA PMA · Coronary drug-eluting stent · Biosensors International USA, Inc.
Key facts
| PMA number | P190020 |
|---|---|
| Trade name | BioFreedom Drug Coated Coronary Stent System |
| Generic name | Coronary drug-eluting stent |
| Applicant | Biosensors International USA, Inc. |
| Product code | NIQ |
| Approval date | Apr 14, 2022 |
| Docket number | 22M-0601 |
| Notice date | Jul 27, 2022 |
| FEI number | 1000124677 |
At a glance
- None Supplements
- Apr 14, 2022 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- No Withdrawn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: