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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS020
Date Received03/30/2001
Decision Date10/10/2001
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional indication, the treatment of restenosis in 316l stainless steel stents, prior to the administration of intravascular brachytherapy, for the cvx-300 excimer laser coronary angioplasty (elca) system. The indication is in addition to those listed in the february 19, 1993, approval letter.
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