Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE |
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 | S023 |
Date Received | 07/31/2002 |
Decision Date | 01/23/2003 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 8870 INTERSTIM APPLICATION SOFTWARE TO OPERATING ON THE MODEL 8840 CLINICIAN PROGRAMMER, USE OF ENHANCED STIMULATION DESKTOP SOFTWARE, AN EXPANDED MEMORY CARD STORAGE, AND UPDATED LABELING. THESE CHANGES ARE USED WITH THE MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY RETENTION AND THE SYMPTOMS OF OVERACTIVE BLADDER, INCLUDING URINARY URGE INCONTINENCE AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY ALONE OR IN COMBINATION, IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS. |
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