|
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 | S007 |
Date Received | 04/03/2017 |
Decision Date | 06/26/2017 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software changes to the Minerva Endometrial Ablation System (i.e., software modifications to 1) correct an error code during device start; 2) to redefine existing error codes to better align them with the observed device conditions; and 3) to add five software checks to the device). |