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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 NameR1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantAVE GALWAY LTD.
PMA NumberP790017
Supplement NumberS071
Date Received03/01/2000
Decision Date08/28/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the r1s rapid exchange balloon dilatation catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The r1s rapid exchange balloon dilatation catheter is not intended for use as a ptca perfusion catheter beyond 60 seconds of balloon inflation.
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