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 |
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 | S049 |
Date Received | 02/26/2008 |
Decision Date | 04/24/2008 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE TECHNICAL MANUAL FOR THE TEST STIMULATION LEAD KIT AND TEST STIMULATION LEAD (MODEL 3065U AND MODEL 3057, RESPECTIVELY) TO EXPLICITLY DESCRIBE THE PRACTICE OF IMPLANTING TWO TEMPORARY TEST STIMULATION LEADS DURING A SINGLE BILATERAL PLACEMENT PROCEDURE FOR SEQUENTIAL TESTING WITHIN THE SEVEN DAY TRIAL PERIOD. |
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