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) | 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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Date Received09/14/1998
Decision Date03/12/1999
Product Code MCX 
Docket Number 99M-2015
Notice Date 06/28/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S036 S037  S045 S034 S035 S001 S002 S003 S004 S008 S009 
S010 S011 S039 S049 S050 S051 S052 S053 S043 S017 S023 S026 
S027 S007 S019 S015 S016 S013 S014 S055 S056 S058 S063 S064 
S065 S038 S040 S046 S042 S041 S054 S044 S047 S048 S006 S024 
S025 S020 S021 S028 S012 S029 S033 S022 S030 S031 S032 S059 
S057 S060 S061 S062 S067 S073 S074 S078 S081 S076 S072 S079 
S080 S084 S087 S089 S090 S066 S068 S069 S071 S075 S070 S077 
S088 S085 S086 S082 S083 S091 
-
-