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 | TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT |
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 | S155 |
Date Received | 04/26/2013 |
Decision Date | 10/22/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING AND PRODUCT SPECIFICATION RELATED TO THE USE OF DIAGNOSTIC ULTRASOUND IMAGING TO HELP GUIDE THE INSERTION OF THE FORAMEN NEEDLE INTO ONE OF THE SACRAL FORAMINA DURING THE ACUTE TEST STIMULATION PROCEDURE. |
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