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. |
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Device | D114S OTW BALLOON DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S074 |
Date Received | 09/14/2000 |
Decision Date | 01/08/2001 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF SIX (6) CATALOGUE ITEMS TO THE APPROVED D114S OVER-THE-WIRE BALLOON DILATATION CATHETER PRODUCT LINE. THESE SIX ITEMS CONSIST OF A 10 MM BALLOON LENGTH IN EACH OF THE CURRENT BALLOON DIAMETERS OF 1.5 MM, 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, AND 4.0 MM. IN ADDITION, APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO THE 1.5 MM DIAMETER EXTRUDED BALLOON TUBING (0.0135"/0.0205" ID/OD FROM THE CURRENT 0.014"/0.022" ID/OD. 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. |
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