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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 NameMEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
PMA NumberP870036
Supplement NumberS039
Date Received06/24/1996
Decision Date08/30/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new balloon sizes to be added to the falcon 20 coronary balloon dilatation catheter line and the addtion of the falcon 30 and falcon 40 coroanry balloon dilatation catheter lines. Also, specification and quality control inspection changes were requested.
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