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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceNOVOSTE BETA-CATH 3.5F SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
BEST VASCULAR, INC
4350 international boulevard
norcross, GA 30093
PMA NumberP000018
Supplement NumberS026
Date Received10/18/2002
Decision Date11/13/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the user's manual, user's guide and customer training to include additional information on scenarios where the beta-rail 3. 5f delivery catheter tip may be subjected to excessive force and the techniques for avoiding and/or resolving these scenarios.
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