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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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435 supplements returned for P970004

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
medtronic interstim therapy system for urinary control

Medtronic Neuromodulation Sep 29, 1997    
medtronic interstim sacral nerve stimulation system

supplement #: S001
Medtronic Neuromodulation Oct 31, 1997 process change - manufacturer/sterilizer/packager/supplier  
medtronic interstim continence control system

supplement #: S002
Medtronic Neuromodulation Jul 08, 1998 change design/components/specifications/material  
medtronic interstim continence control system

supplement #: S003
Medtronic Neuromodulation Nov 02, 1998 change design/components/specifications/material  
interstim therapy for urinary control

supplement #: S004
Medtronic Neuromodulation Apr 15, 1999 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
interstim therapy for urinary control

supplement #: S005
Medtronic Neuromodulation Sep 03, 1999 change design/components/specifications/material  
interstim continence control system

supplement #: S006
Medtronic Neuromodulation Nov 04, 1999 labeling change - indications/instructions/shelf life/tradename  
interstim system for urinary control therapy

supplement #: S007
Medtronic Neuromodulation Feb 29, 2000 labeling change - indications/instructions/shelf life/tradename  
interstim system for urinary control

supplement #: S008
Medtronic Neuromodulation Mar 09, 2000 labeling change - indications/instructions/shelf life/tradename  
interstim sacral nerve stimulation system

supplement #: S009
Medtronic Neuromodulation Oct 18, 2000 change design/components/specifications/material  
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