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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronics Interventional Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP870036
Supplement NumberS039
Date Received06/24/1996
Decision Date08/30/1996
Withdrawal Date06/09/2008
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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