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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 NameELCA CORONARY ATHERECTOMY CATHETERS
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
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: sterilization
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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