• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
Classification Namecatheter, coronary, atherectomy
Generic Namepercutaneous coronary thrombectomy catheter
ApplicantBAYER MEDICAL CARE INC.
PMA NumberP980037
Date Received09/14/1998
Decision Date03/12/1999
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number 99M-2015
Notice Date 06/28/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the angiojet(r) rheolytic(tm) thrombectomy system (angiojet(r) drive unite, angiojet(r) pump set, and angiojet(r) rheolytic(tm) thrombectomy lf140 catheter). This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2. 0mm in diameter prior to balloon angioplasty or stent placement.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 
-
-