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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.
 
Trade NameUSCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantC.R. BARD, INC.
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 - component
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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