PMA supplement
P100018 S053: Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin
FDA PMA supplement · 30-Day Notice · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Key facts
| Original PMA | P100018 |
|---|---|
| Supplement number | S053 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin |
| Generic name | Intracranial aneurysm flow diverter |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product code | OUT |
| Received date | Apr 17, 2026 |
| Decision date | May 15, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: