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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 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.
 
DeviceINTERSTIM THERAPY FOR URINARY CONTROL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS013
Date Received02/22/2001
Decision Date08/17/2001
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
-
-