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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantENDOLOGIX, INC.
11 STUDEBAKER
IRVINE, CA 92618
PMA NumberP970052
Date Received11/04/1997
Decision Date02/20/1998
Withdrawal Date 03/30/2009
Product Code LOX 
Docket Number 98M-0162
Notice Date 03/20/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the FACT(TM), ARC(TM), LYNX(TM) and Guardian(TM) Balloon Coronary Dilatation Catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purposed of improving myocardial perfusion. The application includes authorization from Endosoncis Corp., Rancho Cordova, CA, to incorporate information contained in its approved premarket approval application and related supplements for hte Cathscanner(R) Oracle(R) Micro PTCA Catheter.
Supplements:  S001 S002 
-
-