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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 CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Generic NameDEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
ApplicantSpectranetics (Philips)
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS053
Date Received03/14/2016
Decision Date04/13/2016
Product Code MFA 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.
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