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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(R) FALCON(R) 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 NumberS040
Date Received09/19/1996
Decision Date10/25/1996
Withdrawal Date06/09/2008
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR THE MEDTRONIC(R) FALCON(R) FAMILY OF CORONARY BALLOON DILATATION CATHETERS
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