PMA supplement
P160050 S009: Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
FDA PMA supplement · 30-Day Notice · Intrinsic Therapeutics
Key facts
| Original PMA | P160050 |
|---|---|
| Supplement number | S009 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb |
| Generic name | Reherniation reduction device |
| Applicant | Intrinsic Therapeutics |
| Product code | QES |
| Received date | Jun 5, 2024 |
| Decision date | Jul 3, 2024 |
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: