Premarket Approval (PMA)

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.

• Device: DURA STAR RX PTCA BALLOON DILATATION CATHETER
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Cordis Corp.; 14201 NW 60th Ave.; Miami Lakes, FL 33014
• PMA Number: P880003
• Supplement Number: S095
• Date Received: 09/05/2008
• Decision Date: 09/30/2008
• Reclassified Date: 10/08/2010
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGES TO THE MANUFACTURING PROCESS TO ADDRESS THE POTENTIAL FOR SLOW OR NO DEFLATION OF THE DEVICE.