• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Namesurgical adhesive
ApplicantCRYOLIFE, INC.
PMA NumberP010003
Supplement NumberS005
Date Received04/14/2005
Decision Date01/20/2006
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) addition of two spreader tips, size 12 mm and 16 mm; 2) addition of a green colorant (fda 21 cfr 178. 3297 compliant mbpp 11962) to the collar of the mixing tip for easier visualization of the mating mechanism; 3) modification (blunting the end rather than pointed tip) of the mixing chamber stem end to accept the new applicator tips; 4) modification of the collar formulation for the polypropylene; 5) use of a new material for the spreader extension; and 6) modification of the stem material.
-
-