• 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.
 
DeviceCOSEAL SURGICAL SEALANT
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
BAXTER BIO SCIENCE
32650 n wilson rd
mail stop wg2-3s
round lake, IL 60073
PMA NumberP030039
Supplement NumberS010
Date Received07/01/2008
Decision Date08/18/2008
Product Code
NBE[ Registered Establishments with NBE ]
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 MODIFICATION TO THE 3 ML SYRINGE FOR THE PEG COMPONENT OF THE 2 ML CONFIGURATION OF THE DEVICE.
-
-