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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namescimed maxxum (ptca) catheter
Regulation Number870.5100
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.