• 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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.
-
-