PMA
P170024: Surpass Streamline Flow Diverter
FDA PMA · Intracranial aneurysm flow diverter · Stryker Neurovascular
Key facts
| PMA number | P170024 |
|---|---|
| Trade name | Surpass Streamline Flow Diverter |
| Generic name | Intracranial aneurysm flow diverter |
| Applicant | Stryker Neurovascular |
| Owner/operator | STRYKER CORP. |
| Product code | OUT |
| Approval date | Jul 13, 2018 |
| Docket number | 18M-2884 |
| Notice date | Jul 26, 2018 |
| Establishment registration | 3008853977 |
| FEI number | 3008853977 |
At a glance
- 10–99 Supplements
- Aug 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: