Minerva Endometrial Ablation System

FDA Premarket Approval P140013 S011

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 manufacturing site change to your new facility located at minerva surgical, 4255 burton drive, santa clara, california.   the facility operations at this site involve the manufacturing of the minerva endometrial ablation system disposable handpiece.  

DeviceMinerva Endometrial Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantMINERVA SURGICAL
Date Received2020-01-13
Decision Date2020-02-12
PMAP140013
SupplementS011
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MINERVA SURGICAL 101 Saginaw Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P140013Original 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 IDPMASupp
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

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