Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS023
Date Received01/31/2003
Decision Date05/02/2003
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revised instructions for use that include the adjudicated results from the lars investigation.
-
-