Premarket Approval (PMA)

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 Name: MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE
• Classification Name: stimulator, electrical, implantable, for incontinence
• Generic Name: implantable system for sacral nerve stimulation
• Regulation Number: 876.5270
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P970004
• Supplement Number: S029
• Date Received: 09/20/2004
• Decision Date: 08/04/2005
• Product Code: EZW [ Registered Establishments with EZW ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: normal 180 day track
• Supplement Reason: location change: sterilizer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for: 1) shipment of patient cable (model 041831) after manufacturing to medtronic neurological division, sullivan lake facility, minneapolis, minnesota, for cleaning, packaging and ethylene oxide sterilization, 2) extension of the current 2-year shelf life of the patient cable to 4 years using ethylene oxide sterilization and 3) labeling changes that involve combining the separate manuals for the model 3065u kit and the model 3057 lead into one manual and to replace the combined manual for models 041831, 041829, 041828, 041827 and 041826 with separate single sheet ifus (information for use).