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. |
|
Device | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM |
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 | S197 |
Date Received | 04/20/2015 |
Decision Date | 10/04/2016 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I) and 12 month data from the ongoing, nonrandomized study cohort (Phase II). |
|
|