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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceUSCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP790017
Supplement NumberS065
Date Received02/12/1998
Decision Date03/23/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new ptca catheter line. The device, as modified, will be marketed under the trade name usci(r) apollo(tm) rely(r) sp over-the-wire balloon dilatation catheter with hydro/pel(r) coating and miniquet device and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosisfor the purpose of improving myocardial perfusion.
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