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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.
 
DeviceSpectranetics Laser Sheath (SLS)
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSpectranetics Corp.
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS112
Date Received01/25/2021
Decision Date09/02/2021
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for the next generation Philips Laser System (PLS), including compatibility with the ELCA coronary laser atherectomy catheter, Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.
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