Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Generic NameGlue, surgical, arteries
ApplicantCryolife, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS042
Date Received12/18/2023
Decision Date03/18/2025
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of:• STERIS, located at 1800 Industrial Drive, Libertyville, IL 60048, FEI #1450662, as an alternate sterilization site for the BioGlue Surgical Adhesive syringes• Medline Industries – Northpoint Services, located at 1160 S. Northpoint Blvd, Waukegan, IL 60085, FEI #1000514656, as an alternate sterilization site the Syringe Extender Tips accessory
-
-