|
Device | INTERSTIM SACRAL NERVE STIMULATION 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 | S116 |
Date Received | 05/25/2011 |
Decision Date | 06/08/2011 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF TWO PRECAUTION STATEMENTS TO THE LABELING OF THE MODEL 3037 PATIENT PROGRAMMER. |