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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.
 
DeviceGlidelight Laser Sheath
Generic NameDEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
ApplicantSpectranetics (Philips)
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS070
Date Received01/25/2021
Decision Date09/02/2021
Product Code MFA 
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 the Philips Laser System and for inclusion of the Philips Laser System as a compatible device within the labeling for the ELCA and Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.
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