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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)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronics Interventional Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP870036
Supplement NumberS043
Date Received03/03/1997
Decision Date08/12/1997
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: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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