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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 COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namescimed maxxum (ptca) catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
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 - component
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.
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