FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reherniation Reduction Device
PMA: P160050
·
Supplement: S003
·
Decision Mar 17, 2020
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
- Supplement Number
- S003
- 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
- March 17, 2020
- Date Received
- March 19, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval to change the supplier and specifications of the polyester yarn used to make the mesh of the woven fabric for the flexible occlusion component of the Barricaid Anular Closure Device (ACD).
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 |