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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.
 
DeviceUSCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS062
Date Received05/30/1997
Decision Date12/01/1997
Reclassified Date 10/08/2010
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 PTCA catheter line. The device, as modified, will be marketed under the trade name USCI* Apollo* Rely Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel* Coating and Miniquet* Device 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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