HDE supplement
H170004 S034: PK Papyrus Covered Coronary Stent System
FDA HDE supplement · special (immediate track) · BIOTRONIK, Inc.
Key facts
| Original HDE | H170004 |
|---|---|
| Supplement number | S034 |
| Supplement type | special (immediate track) |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | PK Papyrus Covered Coronary Stent System |
| Generic name | Coronary covered stent |
| Applicant | BIOTRONIK, Inc. |
| Product code | NIV |
| Received date | Jan 28, 2025 |
| Decision date | Apr 11, 2025 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: