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 SACRAL NERVE STIMULATION (SNS) 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 | S033 |
Date Received | 09/30/2005 |
Decision Date | 06/30/2006 |
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 MODIFICATIONS TO THE INTERSTIM NEUROSTIMULATOR (MODEL 3058 INTERSTIM II), PATIENT PROGRAMMER (MODEL 3037 ICON), THERAPY APPLICATION SOFTWARE, TINED LEADS (MODELS 3889/3093), SYSTEM ACCESSORIES (MODEL 37092 EXTERNAL ANTENNA, TORQUE HEX WRENCH, TUNNELING TOOL), AND LABELING ARCHITECTURE. |
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