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 NamePOSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE
Generic Namepercutaneous coronary thrombectomy catheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS002
Date Received02/29/2000
Decision Date03/17/2000
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 additiion of a label to the current inventory of the lf 140 catheter which reads "caution: do not inject fluids in catheter outflow lumen".
-
-