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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS067
Date Received03/23/1998
Decision Date09/18/1998
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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