Identity
- Trade Name
- PROGEL PLEURAL AIR LEAK SEALANT FDA PMA
- Generic Name
- Sealant, polymerizing FDA PMA
Identifiers
- PMA Number
- P010047 FDA PMA
- FDA Product Code
- NBE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Anesthesiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Progel Pleural Air Leak Sealant is a polymerizing sealant designed to address visible air leaks during surgical procedures. It is indicated for application to the visceral pleura during an open thoracotomy following standard closure methods, such as sutures or staples, for lung parenchyma resection.
This device is authorized under FDA PMA P010047. It is intended for use by medical professionals in a clinical setting to manage air leaks measuring 2 mm or greater incurred during lung surgery.
Frequently asked questions
What is the primary use of Progel Pleural Air Leak Sealant?
The sealant is indicated for application to the visceral pleura during an open thoracotomy to manage visible air leaks of 2 mm or greater that occur during the resection of lung parenchyma.
When should this sealant be applied during surgery?
It is intended for use after standard visceral pleural closure techniques, such as the application of sutures or staples, have already been performed.
Is this device FDA authorized?
Yes, Progel Pleural Air Leak Sealant has received FDA PMA approval under the reference number P010047.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P010047 | Class III | Active |
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Manufacturer
- Manufacturer
- Neomend, Inc.
Sources (1)
- FDA PMA P010047 24 fields · synced Sep 18, 2026