|
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 | S005 |
Date Received | 10/04/2016 |
Decision Date | 05/15/2017 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Clinical Trials | NCT01569763
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a CO2 extension tube and sheath marking to the Minerva Handpiece and software modifications to the gas management module in the RF controller. |