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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBETA-CATH(TM) SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
BEST VASCULAR, INC
4350 international boulevard
norcross, GA 30093
PMA NumberP000018
Supplement NumberS013
Date Received04/24/2001
Decision Date10/18/2001
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
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