PMA
P160050: BARRICAID ANULAR CLOSURE DEVICE (ACD)
FDA PMA · Reherniation reduction device · Intrinsic Therapeutics
Key facts
| PMA number | P160050 |
|---|---|
| Trade name | BARRICAID ANULAR CLOSURE DEVICE (ACD) |
| Generic name | Reherniation reduction device |
| Applicant | Intrinsic Therapeutics |
| Owner/operator | Intrinsic Therapeutics Inc. |
| Product code | QES |
| Approval date | Feb 8, 2019 |
| Docket number | 19M-0802 |
| Notice date | Feb 19, 2019 |
| Establishment registration | 3006232063 |
| FEI number | 3006232063 |
At a glance
- 10–99 Supplements
- Mar 24, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: