Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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 NameINTERSTIM THERAPY FOR URINARY CONTROL
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS013
Date Received02/22/2001
Decision Date08/17/2001
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3550-03 twist-lock screening cable and model 3550-05 percutaneous extension and tunneling tool kit for temporary sacral nerve stimulation as part of a staged implant technique for the medtronic(r) interstim(r) therapy for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.
-
-