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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: S031  S043 S049 S023 S025 S026 S027 S028 S029 S030 S004 
S047 S035 S036 S037 S052 S045 S041 S001 S002 S005 S012 S013 
S014 S022 S017 S008 S054 S055 S056 S057 S003 S006 S032 S033 
S050 S046 S042 S038 S039 S040 S034 S051 S048 S009 S007 S019 
S020 S021 S010 S053 S058 S059 S063 S066 S067 S069 S071 S060 
S061 S062 S064 S068 S065 S070 
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