Duraseal Dural Sealant System
by Integra Lifesciences Corporation
PMA P040034
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP040034 | Date7 Apr 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Sealant, dural
- PMA Number
- FDA Product Code
- NQR
- Device Class
- Class III
- Advisory Committee
- Neurology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The DURASEAL Dural Sealant System is a dural sealant indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. It is designed to be used with autologous duraplasty material to enhance the seal of the dura mater following surgical intervention.
The device is supplied as a sterile, single-use system intended for use in the operating room during cranial procedures. It is regulated as a Class III medical device under FDA PMA approval (P040034) and must be used in accordance with the manufacturer's instructions for use, including storage and handling requirements specified in the labeling.
Other devices from Integra Lifesciences Corporation
Questions
AI-generated answers, 18 Sep 2026
What is the DURASEAL Dural Sealant System used for?
The DURASEAL Dural Sealant System is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. It is specifically designed to be used alongside autologous duraplasty material to support the sealing of the dura mater after surgical incision or trauma.
Is the DURASEAL Dural Sealant System reusable or single-use?
The DURASEAL Dural Sealant System is supplied as a sterile, single-use device. It is intended for one-time use during a surgical procedure and must not be reprocessed or reused, as doing so could compromise sterility, performance, and patient safety.
What regulatory authorization does the DURASEAL Dural Sealant System have?
The DURASEAL Dural Sealant System has received FDA Premarket Approval (PMA) under application number P040034. This authorization confirms its regulatory status as a Class III medical device cleared for commercial distribution in the United States.