HDE
H140001: IMPELLA RP SYSTEM
FDA Humanitarian Device Exemption · ABIOMED, INC.
Key facts
| HDE number | H140001 |
|---|---|
| Trade name | IMPELLA RP SYSTEM |
| Generic name | Right ventricular bypass (assist) device |
| Applicant | ABIOMED, INC. |
| Owner/operator | ABIOMED, INC. |
| Product code | OJE |
| Approval date | Jan 23, 2015 |
| Docket number | 15M-0267 |
| Notice date | Feb 9, 2015 |
| Establishment registration | 1220648 |
| FEI number | 1220648 |
At a glance
- 1–9 Supplements
- Feb 27, 2017 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- 1–9 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: