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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.
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
PMA NumberP000052
Date Received12/18/2000
Decision Date11/02/2001
Withdrawal Date 01/31/2008
Product Code
MOU[ Registered Establishments with MOU ]
Docket Number 01M-0508
Notice Date 11/14/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the galileo intravascular radiotherapy system which consists of the galileo source delivery unit, 27 mm galileo centering catheter, and 27 mm 32p source wire. 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 <= 47 mm in reference vessel diameter 2. 4 mm to 3. 7 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025