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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.
 
DeviceELCA CORONARY ATHERECTOMY CATHETERS
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
SPECTRANETICS CORP.
9965 federal drive
colorado springs, CO 80921
PMA NumberP910001
Supplement NumberS051
Date Received11/30/2011
Decision Date02/17/2012
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.
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