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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 NameD114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantAVE GALWAY LTD.
PMA NumberP790017
Supplement NumberS072
Date Received07/14/2000
Decision Date07/24/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in supplier of the high molecular weight high-density polyethylene inner shaft used in ave ireland's manufacturing neptune(tm) x-act(r) and d114s over-the-wire ptca catheters operations.
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