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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 NameSPECTRANETICS LASER CATHETERS ELCA
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS045
Date Received02/04/2011
Decision Date07/14/2011
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to pyrogen testing procedures and sampling.
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