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 THERAPY, 3080/3886 LEAD KITS |
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 | S011 |
Date Received | 01/22/2001 |
Decision Date | 02/05/2001 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ALTERNATIVE TUNGSTEN STYLET FOR LEAD KITS 3080/3886 AND MINOR CHANGES TO THE LABELING. |
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