• 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 NumberS014
Date Received05/14/2009
Decision Date06/26/2009
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR PRINTING THE PRODUCT NAME ON THE SYRINGE BODY.
-
-