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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 Dr.
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
Predetermined Change Control Plan AuthorizedNo
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: S029 S030 S049 S045 S031 S003  S001 S002 S005 S023 S025 
S026 S027 S028 S007 S009 S047 S041 S052 S022 S017 S004 S054 
S055 S006 S035 S032 S033 S042 S050 S046 S036 S037 S038 S039 
S034 S043 S051 S048 S040 S019 S020 S021 S010 S008 S012 S013 
S014 S056 S057 S061 S053 S058 S064 S060 S062 S063 S059 S066 
S068 S069 S065 S067 S070 S071 S072 S073 
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