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 | INTERSTIM(R) THERAPY FOR URINARY CONTROL |
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 | S012 |
Date Received | 02/20/2001 |
Decision Date | 08/06/2001 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODEL 3031A PATIENT PROGRAMMER FOR USE WITH THE MEDTRONIC(R) INTERSTIM(R) THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY/FREQUENCY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS. |
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