FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Polymerizing
PMA: P010047
·
Supplement: S028
·
Decision Nov 8, 2013
Classifications
1
FEI Numbers
15
Registration Numbers
15
Basic Information
- Device Name
- Sealant, Polymerizing
- Trade Name
- PROGEL PLEURAL AIR LEAK SEALANT
- PMA Number
- P010047
- Supplement Number
- S028
- Device Class
- FDA Class 3
- Product Code
- NBE
- Generic Name
- Sealant, polymerizing
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 8, 2013
- Date Received
- March 7, 2013
- 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 STUDY 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 |
|---|---|---|---|
| NBE | Sealant, Polymerizing | FDA class 3 | Unknown |