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 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 | S073 |
Date Received | 04/28/2009 |
Decision Date | 10/26/2009 |
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 CHANGES TO THE EXISTING MODEL 3093 AND MODEL 3889 INTERSTIM TINED LEADS, THE ADDITION OF AN ALTERNATIVE STYLET DESIGN TO BE INCLUDED IN THE MODEL 3093 AND MODEL 3889 LEADS KITS, AND A MINOR REVISION TO THE LABELING TO UPDATE THE LIST OF PACKAGE CONTENTS FOR THE MODEL 3093 AND MODEL 3889 LEADS KITS. |
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