PMA supplement
P160050 S001: Barricaid Anular Closure Device
FDA PMA supplement · Normal 180 Day Track No User Fee · Intrinsic Therapeutics
Key facts
| Original PMA | P160050 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Barricaid Anular Closure Device |
| Generic name | Reherniation reduction device |
| Applicant | Intrinsic Therapeutics |
| Product code | QES |
| Received date | Mar 8, 2019 |
| Decision date | May 7, 2019 |
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: