Devices@FDA

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New Search Back to Search Results 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 Name DURA STAR RX PTCA BALLOON DILATATION CATHETER Classification Name catheters, transluminal coronary angioplasty, percutaneous Generic Name percutaneous transluminal angioplasty catheter Applicant CORDIS CORP. PMA Number P880003 Supplement Number S095 Date Received 09/05/2008 Decision Date 09/30/2008 Product Code LOX [ Registered Establishments with LOX ] Advisory Committee Cardiovascular Supplement Type 30-day notice Supplement Reason process change: manufacturing Expedited Review Granted? No Approval Order Statement  Changes to the manufacturing process to address the potential for slow or no deflation of the device.

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