|
Device | INTERSTIM II, MODEL 3058 NEUROSTIMULATOR |
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 | S108 |
Date Received | 03/14/2011 |
Decision Date | 08/19/2011 |
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 CHANGES TO THE PROCEDURE FOR CONFIRMING THAT THE ULTRASONIC STAKING OF TWO WASHERS HAS BEEN PERFORMED AND A MODIFICATION OF A TOOL USED TO ENSURE THE SETSCREW IS PRESENT IN THE SETSCREW BLOCK. |