|
Device | INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE, N.E. MINNEAPOLIS, MN 55432 |
PMA Number | P970004 |
Supplement Number | S060 |
Date Received | 07/24/2008 |
Decision Date | 10/17/2008 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY. |