FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Dural
PMA: P080013
·
Supplement: S001
·
Decision Jun 29, 2010
Classifications
1
FEI Numbers
13
Registration Numbers
13
Basic Information
- Device Name
- Sealant, Dural
- Trade Name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- PMA Number
- P080013
- Supplement Number
- S001
- 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
- June 29, 2010
- Date Received
- October 6, 2009
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL PROTOCOL.
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 |