FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reherniation Reduction Device
PMA: P160050
·
Decision Feb 8, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Reherniation Reduction Device
- Trade Name
- BARRICAID ANULAR CLOSURE DEVICE (ACD)
- PMA Number
- P160050
- Device Class
- FDA Class 3
- Product Code
- QES
- Generic Name
- Reherniation reduction device
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 8, 2019
- Date Received
- November 10, 2016
- Expedited Review
- N
- Docket Number
- 19M-0802
Advisory Committee Statement
Approval for the Barricaid Anular Closure Device (ACD). The device is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large anular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QES | Reherniation Reduction Device | FDA class 3 | Unknown |