FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sealant, Polymerizing
PMA: P010047
·
Supplement: S073
·
Decision Mar 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Sealant, Polymerizing
- Trade Name
- PROGEL Pleural Air Leak Sealant
- PMA Number
- P010047
- Supplement Number
- S073
- Device Class
- FDA Class 3
- Product Code
- NBE
- Generic Name
- Sealant, polymerizing
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 12, 2026
- Date Received
- February 17, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
For the reduction of testing frequency for Air Flow Test, Standard Spray Tips and Extended Spray Tips; removal of Neomend Inc. Pouch Peel Strength Testing for Incoming Packaging Materials with the adoption of Supplier-Performed ASTM F88 Testing for Chevron Seal Pouches; and elimination of SDS-PAGE Lot Release Testing
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 |