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

DeviceMinerva Endometrial Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantMINERVA SURGICAL
Date Received2020-11-25
Decision Date2021-02-17
PMAP140013
SupplementS012
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MINERVA SURGICAL 101 Saginaw Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P140013Original Filing
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 IDPMASupp
00862393000162 P140013 000
00862393000155 P140013 000
00862393000131 P140013 000
00862393000117 P140013 000

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