• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesealant, dural
Generic Namesealant, dural
800-12 capitola drive
durham, NC 27713
PMA NumberP130014
Date Received05/14/2013
Decision Date03/30/2015
Product Code
NQR[ Registered Establishments with NQR ]
Docket Number 15M-1065
Notice Date 04/17/2015
Advisory Committee Neurology
Clinical Trials NCT01158378
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the adherus autospray dural sealant. This device is indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as when using sutures, to providewatertight closure during cranial procedures.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002