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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.
 
DeviceELCA Laser Catheters
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSpectranetics Corp.
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS096
Date Received07/27/2017
Decision Date08/25/2017
Product Code LPC 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implement a semi-automated dimensional verification for the radiopaque markers.
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