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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 Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
9965 federal drive
colorado springs, CO 80921
PMA NumberP910001
Supplement NumberS026
Date Received11/16/2006
Decision Date05/11/2007
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of a coating on the inner lumen of the extreme catheter model numbers 114-001, 117-002, and 120-001, the change to black tubing for 0. 9 mm catheter model numbers 110-003 and 110-004 x-80, and the change in the strain relief material durometer for the 0. 9 mm extreme catheter model numbers 110-001, 110-002, 110-152 and 0. 7 mm extreme catheter model 110-005 to prevent kinking at the strain relief.