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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.
 
DeviceSPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
SPECTRANETICS CORP.
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.
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