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.
 
DeviceSCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantScimed Life Systems, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS131
Date Received10/03/1997
Decision Date06/29/1998
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification of the SCIMED Ranger(TM) PTCA Catheter, with the primary difference being use of a new balloon material. The device, as modified, will be marketed under the trade name SCIMED(R) COYOTE(TM) Percutaneous Transluminal Angioplasty Coronary (PTCA) Catheter and is indicated for the balloon dilatation of coronary arteries or bypass graft stenoses for the prupose of improving myhocardial perfusion and (balloon models 2.5-4.0 mm only) the post-delivery expansion of balloon expandable stents.
-
-