HDE
H160002: PulseRider Aneurysm Neck Reconstruction Device
FDA Humanitarian Device Exemption · Medos International, SARL
Key facts
| HDE number | H160002 |
|---|---|
| Trade name | PulseRider Aneurysm Neck Reconstruction Device |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Owner/operator | Medos International SARL |
| Product code | NJE |
| Approval date | Jun 19, 2017 |
| Docket number | 17M-3839 |
| Notice date | Jun 23, 2017 |
| Establishment registration | 3008114965 |
| FEI number | 3008114965 |
At a glance
- 10–99 Supplements
- Apr 17, 2020 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: