FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Dural
PMA: P220014
·
Supplement: S004
·
Decision Feb 11, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Basic Information
- Device Name
- Sealant, Dural
- Trade Name
- CraniSeal Dural Sealant
- PMA Number
- P220014
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- NQR
- Generic Name
- Sealant, dural
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 11, 2025
- Date Received
- November 12, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change to the syringes that contain the precursor and diluent solution components.
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 |
|---|---|---|---|
| NQR | Sealant, Dural | FDA class 3 | Unknown |