Minerva Endometrial Ablation System

FDA Premarket Approval P140013 S012

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.

Pre-market Approval Supplement Details

Approval for a design change to the check valve located on the disposable handpiece

• Device: Minerva Endometrial Ablation System
• Generic Name: Device, Thermal Ablation, Endometrial
• Applicant: MINERVA SURGICAL
• Date Received: 2020-11-25
• Decision Date: 2021-02-17
• PMA: P140013
• Supplement: S012
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: MINERVA SURGICAL 101 Saginaw Drive redwood City, CA 94063

Supplemental Filings

Supplement Number	Date	Supplement Type
P140013		Original Filing
S013	2021-12-23	30-day Notice
S012	2020-11-25	Real-time Process
S011	2020-01-13	Normal 180 Day Track No User Fee
S010	2018-04-09	Real-time Process
S009	2018-01-31	Real-time Process
S008
S007	2017-04-03	Real-time Process
S006	2017-02-07	Normal 180 Day Track No User Fee
S005	2016-10-04	Normal 180 Day Track
S004	2016-09-20	Normal 180 Day Track No User Fee
S003	2016-07-05	Real-time Process
S002	2016-04-08	Normal 180 Day Track No User Fee
S001	2015-12-28	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00862393000162	P140013	000
00862393000155	P140013	000
00862393000131	P140013	000
00862393000117	P140013	000
00862393000148	P140013	000
00862393000148	P140013	012
00862393000117	P140013	012
00862393000162	P140013	012
00862393000100	P140013	012
00862393000131	P140013	012