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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.
 
DeviceFIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP880003
Supplement NumberS094
Date Received02/25/2008
Decision Date04/15/2008
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS TO ADDRESS THE POTENTIAL FOR SLOW OR NO DEFLATION OF THE FIRE STAR RX PTCA BALLOON DILATATION CATHETER AND DURA STAR? RX PTCA BALLOON DILATATION CATHETER.
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