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.
 
DeviceTRIDYNE VASCULAR SEALANT, TRIDYNE EXTENDED APPLICATOR SPRAY TIP.
Generic NameSealant, polymerizing
ApplicantNeomend, Inc.
60 Technology Dr.
Irvine, CA 92618
PMA NumberP150016
Supplement NumberS002
Date Received10/19/2016
Decision Date12/19/2016
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of alternate suppliers of testing services and reagents for quality testing of the Tridyne Vascular Sealant.
-
-