|
Device | NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S067 |
Date Received | 03/23/1998 |
Decision Date | 09/18/1998 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
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. |