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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
 
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239 supplements returned for P030005

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Device Name Company Date Approved Supplement Reason Other Information
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

Guidant Corp. Jan 26, 2004   Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
contak renewal tr, models h120, h125

supplement #: S001
Guidant Corp. Mar 03, 2004 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr (model h120 and h125)

supplement #: S002
Guidant Corp. Jun 28, 2004 labeling change - indications/instructions/shelf life/tradename  
contak renewal tr

supplement #: S003
Guidant Corp. Aug 06, 2004 change design/components/specifications/material  
contack renewal tr

supplement #: S004
Guidant Corp. Nov 19, 2004 process change - manufacturer/sterilizer/packager/supplier  
guidant contak renewal tr models h125 and h120

supplement #: S005
Guidant Corp. Mar 08, 2005 labeling change - indications/instructions/shelf life/tradename  
contak renewal tr

supplement #: S006
Guidant Corp. Dec 22, 2004 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S008
Guidant Corp. Apr 08, 2005 change design/components/specifications/material  
vitality avt icds models a135, a155

supplement #: S009
Guidant Corp. Jul 21, 2005 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S010
Guidant Corp. Jul 08, 2005 process change - manufacturer/sterilizer/packager/supplier  
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