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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameSCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS131
Date Received10/03/1997
Decision Date06/29/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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.
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