PMA supplement
P100018 S015: Pipeline Flex Embolization Device
FDA PMA supplement · Panel Track · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Key facts
| Original PMA | P100018 |
|---|---|
| Supplement number | S015 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Pipeline Flex Embolization Device |
| Generic name | Intracranial aneurysm flow diverter |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product code | OUT |
| Received date | Jun 28, 2017 |
| Decision date | Dec 14, 2018 |
| Docket number | 18M-4779 |
| Notice date | Jan 25, 2019 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: