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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.
 
Trade NameGALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
ApplicantGUIDANT CORP.
PMA NumberP000052
Supplement NumberS004
Date Received12/11/2001
Decision Date09/19/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the galileo iii intravascular radiotherapy system. The device, as modified, will be marketed under the trade name galileo iii intravascular radiotherapy system and is indicated as follows: "the galileo iii intravascular radiotherapy system is intended 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 a reference vessel diameter 2. 4 mm to 3. 7 mm. ".
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