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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) FAMILY OF 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 NumberS038
Date Received04/16/1996
Decision Date09/25/1996
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 THE INTRODUCTION OF A NEW PRODUCT LINE. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MILLENIA CORONARY BALLOON DILATATION CATHETER
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