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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameBETA-CATH (TM) SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular brachytherapy system
ApplicantBEST VASCULAR, INC
PMA NumberP000018
Date Received04/17/2000
Decision Date11/03/2000
Product Code
MOU[ Registered Establishments with MOU ]
Docket Number 00M-1649
Notice Date 12/13/2000
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 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 Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 
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