PMA
P100018: PIPELINE EMBOLIZATION DEVICE
FDA PMA · Intracranial aneurysm flow diverter · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Key facts
| PMA number | P100018 |
|---|---|
| Trade name | PIPELINE EMBOLIZATION DEVICE |
| Generic name | Intracranial aneurysm flow diverter |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Owner/operator | Medtronic, Inc. |
| Product code | OUT |
| Approval date | Apr 6, 2011 |
| Docket number | 11M-0284 |
| Notice date | Apr 20, 2011 |
| Establishment registration | 2029214 |
| FEI number | 1000220862 |
At a glance
- 10–99 Supplements
- Jul 21, 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- No Withdrawn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: