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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
ApplicantSpectranetics (Philips)
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS001
Date Received12/12/1997
Decision Date06/16/1998
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the 12 French Outer Sheath. The device is an accessory to the 12 French Laser Sheath and will be packaged in the 12 French Laser Sheath Kit.
-
-