• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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.
Classification Namedevice, angioplasty, laser, coronary
Generic Nameexcimer laser
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.
Supplements: S001 S002 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 
S023 S024 S025 S026 S027 S028 S031 S032 S033 
S034 S037 S038 S040 S041 S042 S043 S044 S045 
S047 S048 S049 S050 S051 S052 S053 S054 S055 
S056 S057 S058 S059 S060 S061 S062 S063 S064 
S065 S066 S067 S069 S070 S071 S073