|
Device | SNS BOWEL INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS |
Generic Name | Implanted electrical device intended for treatment of fecal incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MS RCW225 MINNEAPOLIS, MN 55432 |
PMA Number | P080025 |
Supplement Number | S033 |
Date Received | 05/09/2012 |
Decision Date | 06/07/2012 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES. |