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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Classification Namedevice, removal, pacemaker electrode, percutaneous
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Date Received11/26/1996
Decision Date12/09/1997
Product Code
MFA[ Registered Establishments with MFA ]
Docket Number 98M-0451
Notice Date 07/14/1998
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 
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