• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVASOSEAL (TM)
Classification Namedevice, hemostasis, vascular
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP920004
Date Received02/03/1992
Decision Date09/29/1995
Withdrawal Date 12/06/2013
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 95m-0394
Notice Date 12/15/1995
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the vasoseal vascular hemostasis device (vhd) in addition to indication already mentioned also indicated for use in ptca patients when immediate sheath removal is desired.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 
-
-