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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 NameNEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantC.R. BARD IRELAND, LTD.
PMA NumberP790017
Supplement NumberS067
Date Received03/23/1998
Decision Date09/18/1998
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 to market new ptca catheter models. The devices, as modified, will be marketed under the trade names usci(r) neptune(tm) x-act(r) and the neptune(tm) x-act(r) duo over-the-wire balloon dilatation catheters with hydro/pel(r) coating and anti back bleed device and are 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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