Food and Drug Administration
November 30, 2004
DuraSeal Dural Sealant System (P040034)
Briefing Information
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Panel Recommendation Options for Premarket Approval Application (HTM) (PDF) (Word)
Executive Summary (PDF)
DuraSeal™ Dural Sealant System PMA040034, Confluent Surgical, Inc, (HTM) (PPT)
Instructions For Use (PDF)
Clinical Summary (PDF)