|
Device | MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM |
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 | S020 |
Date Received | 08/10/2011 |
Decision Date | 09/06/2011 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2. |