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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 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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
one scimed place
maple grove, MN 55311-1566
PMA NumberP860019
Supplement NumberS146
Date Received06/30/1998
Decision Date08/10/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following additional models of the COYOTE(TM) PTCA Catheter: a)the addition of 1/4 mm balloon diameter sizes from 2.25 mm to 3.75 mm for the 20 mm balloon length; b) balloon lengths of 9 mm, 15 mm, and 25 mm in balloon diameters of 2.5 mm to 4.0 mm in 1/4 mm increments; and c) balloon lengths of 20 mm and 40 mm in balloon diameters of 2.0 mm to 4.0 mm in 1/4 mm increments. These PTCA catheter models are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The 2.5 mm - 5.0 mm balloon models are also indicated for ht epost-delivery expansion of balloon expandable stents.