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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 NameCROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP810046
Supplement NumberS205
Date Received12/19/2000
Decision Date01/24/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revision of the crosssail and opensail coronary dilatation catheter's compliance charts. These catheters are indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and 2) 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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