FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Dural
PMA: P080013
·
Supplement: S030
·
Decision Feb 27, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Sealant, Dural
- Trade Name
- DuraSeal Exact Spine Sealant System
- PMA Number
- P080013
- Supplement Number
- S030
- 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 27, 2026
- Date Received
- November 24, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for the extension of shelf-life to 18 months.
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 |