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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 NameSPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Classification Namedevice, angioplasty, laser, coronary
Generic Nameexcimer laser
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Date Received02/08/1991
Decision Date02/19/1993
Product Code
LPC[ Registered Establishments with LPC ]
Docket Number 93M-0086
Notice Date 03/24/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the spectranetics cvx-300(tm) excimer laser system, including the models pc1014 and pc1017 laser catheters. This system is indicated for use in patients with single or multivessel coronary artery disease either as a stand alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (ptca) and who are acceptable candidates for coronary artery bypass graft (cabg) surgery. Adjunctive balloon angioplasty was performed, at the clinical investigator's discretion, in 84 percent of the lesions treated. Clinical experience has provided reasonable assurance that the spectraneticics cvx-300(tm) excimer laser system and multifiber laser catheters are safe and effective for the following indications:occluded saphenous vein bypass grafts; ostial lesions; long lesions (greater than 20 mm in length); moderately calcified stenoses (heavily calcified stenoses are those lesions that demonstrate complete calcification when identified under fluoroscopy prior to the procedure. Moderately and slightly calcified stenoses are all others. ); total occlusions traversable by a guidewire; and lesions which have previously failed balloon angioplasty (this includes those lesions that were treated unsuccessfully by ptca. Lesions that have undergone a complicated ptca procedure are not included in this category. ) these lesions must be traversable by a guidewire and composed of athersclerotic plaque and/or calcified material. The lesions should be well defined by angiography.
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