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 | SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL |
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 | S161 |
Date Received | 09/23/2013 |
Decision Date | 10/22/2013 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS. |
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