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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.
Classification Nameintravascular radiation delivery system
PMA NumberP000018
Supplement NumberS016
Date Received08/07/2001
Decision Date01/30/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revised post-approval study protocol for the 30 mm and 40 mm bet systems. The revised post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigations, are successful in reducing the device failure and malfunction rate.