Food and Drug Administration

Neurological Devices Panel

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)