• 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
325 paramount drive
raynham, MA 02767-0350
PMA NumberP990040
Supplement NumberS007
Date Received12/19/2008
Decision Date02/06/2009
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes and modifications as follows: 1) the transfer of the manufacturing of the trufill n-bca liquid embolic system fromone building to another within the same facility;2) a clarification of the instructions for use (1fu)the removal of a redundant incoming receiving inspection for the n-bca and tantalumpouch;3) the removal of a specification for the n-bca and tantalum pouch; and4) modification of the seal specifications for the n-bca and tantalum pouch.