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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.
 
DeviceTHE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
3576 UNO CAL PLACE
SANTA ROSA, CA 95403
PMA NumberP870036
Supplement NumberS044
Date Received05/20/1998
Decision Date11/17/1998
Withdrawal Date 06/09/2008
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new product line. The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) 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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