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.
 
DeviceBETA-CATH (TM) SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBest Vascular, Inc.
4350 International Blvd.
Norcross, GA 30093
PMA NumberP000018
Date Received04/17/2000
Decision Date11/03/2000
Product Code MOU 
Docket Number 00M-1649
Notice Date 12/13/2000
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE BETA-CATH(TM) SYSTEM. THE DEVICE IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S045  S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 
S021 S022 S023 S024 S025 S026 S027 S040 S041 S035 S036 S037 
S038 S039 S001 S002 S033 S034 S048 S028 S029 S030 S031 S032 
S042 S043 S044 S050 S046 S014 S015 S016 S017 S018 S019 S051 
S047 
-
-