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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameTHORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS024
Date Received12/11/2002
Decision Date12/31/2002
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a warning statement to the package labels and to the instructions for use for the beveled-tip atrial cannula, as used with the thoratec ventricular assist device (vad) system.
-
-