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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) MS2(TM) BALLOON SHAPING TOOL
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronics Interventional Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP870036
Supplement NumberS042
Date Received01/29/1997
Decision Date07/28/1997
Withdrawal Date06/09/2008
Product Code LOX 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.
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