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 SYSTEM 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 | S020 |
Date Received | 01/16/2002 |
Decision Date | 02/04/2002 |
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 1) THE ADDITION OF TEST STIMULATION CABLES TO THE EXISTING MODEL 3057 TEST STIMULATION LEAD PACKAGE AND THE MODEL 3065U TEST STIMULATION LEAD KIT, AND 2) ASSOCIATED LABELING REVISIONS TO THE MODEL 3065U INTERSTIM TEST STIMULATION LEAD KIT TECHNICAL MANUAL AND THE INTERSTIM TEST STIMULATION COMPONENTS INSTRUCTIONS FOR USE. |
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