HDE
H170004: PK Papyrus Covered Coronary Stent System
FDA Humanitarian Device Exemption · BIOTRONIK, Inc.
Key facts
| HDE number | H170004 |
|---|---|
| Trade name | PK Papyrus Covered Coronary Stent System |
| Generic name | Coronary covered stent |
| Applicant | BIOTRONIK, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | NIV |
| Approval date | Sep 14, 2018 |
| Docket number | 18M-3505 |
| Notice date | Sep 17, 2018 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 10–99 Supplements
- Jul 23, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 100–999 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: