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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 NameEXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS059
Date Received07/02/2012
Decision Date04/04/2013
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 a change to an adhesive primer used in the manufacture of the elca eccentric (ell) devices. Previously, you have used loctite 793 which has been discontinued by the vendor. You have changed the primer to loctite 7701, a medical grade adhesive primer used for the same purpose.
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