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 NameFLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecoronary atherectomy catheter
ApplicantGUIDANT CORP.
PMA NumberP890043
Supplement NumberS038
Date Received12/21/2004
Decision Date01/14/2005
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).
-
-