• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCOSEAL SURGICAL SEALANT (PREMIXED)
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
ANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 s.w 47th avenue
gainesville, FL 32608
PMA NumberP010022
Supplement NumberS001
Date Received08/09/2002
Decision Date02/04/2003
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) change in packaging of the polymer resins to a pre-mixed configuration; 2) change in buffer a to a dilute hydrogen chloride solution with a ph of 2. 2; 3) change in sterilization to gamma radiation; and 4) change to room temperature storage.
-
-