• 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.
 
DeviceBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
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 change design/components/specifications/material
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.
-
-