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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 NameRX CHASSIS I CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP810046
Supplement NumberS203
Date Received10/17/2000
Decision Date01/11/2001
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 rx chassis 1(tm) coronary dilatation catheter. The device, as modified, is indicated for a) balloon dilatation of the stenotic portion of a coronary artery of bypass graft stenosis for the purpose of improving myocardial perfusion, and b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st segment elevation myocardial infarction.
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