|
Device | Minerva Endometrial Ablation System |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MINERVA SURGICAL 101 SAGINAW DRIVE REDWOOD CITY, CA 94063 |
PMA Number | P140013 |
Supplement Number | S006 |
Date Received | 02/07/2017 |
Decision Date | 08/07/2017 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Clinical Trials | NCT01569763
|
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 labeling changes to update the clinical study results to reflect the final 2- and 3-year follow-up results from the Minerva Single-Arm study, as well as the 1-year follow-up results from the Minerva Randomized Control Trial. |