FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Polymerizing
PMA: P010047
·
Supplement: S065
·
Decision Feb 9, 2022
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
- S065
- 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
- February 9, 2022
- Date Received
- March 2, 2021
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling changes.
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 |