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 THERAPY SYSTEM
• Classification Name: stimulator, electrical, implantable, for incontinence
• Generic Name: implantable system for sacral nerve stimulation
• Regulation Number: 876.5270
• Applicant: MEDTRONIC INC.
• PMA Number: P970004
• Supplement Number: S137
• Date Received: 07/13/2012
• Decision Date: 08/10/2012
• Product Code: EZW [ Registered Establishments with EZW ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Addition of a duplicate eto sterilization system.