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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Generic NameDEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
ApplicantSpectranetics (Philips)
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP960042
Date Received11/26/1996
Decision Date12/09/1997
Product Code MFA 
Docket Number 98M-0451
Notice Date 07/14/1998
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the 12 French Laser Sheath Kit which consists of the 12 French Laser Sheath (Model 500-001) and Fish Tape accessory. The device is indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S017 S019 S020 S021 S022 S023 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S045 S046 S047 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 
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