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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 NumberP990036
Supplement NumberS001
Date Received02/13/2001
Decision Date06/13/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the existing radiation dosimetry protocol from a protocol that is based on intravascular ultrasound (ivus) to a protocol that prescribes a fixed dose of 14 gy at a distance of 2 mm from the centerline of the source and is indicated for the treatment of native coronary arteries (2. 75 - 4. 0 mm in diameter and lesions up to and including 45 mm in length) with in-stent restenosis following percutaneous revascularization using current interventional techniques.