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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSpectranetics Corp.
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS059
Date Received07/02/2012
Decision Date04/04/2013
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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. THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.
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