Mara Water Vapor Ablation System

FDA Premarket Approval P160047 S028

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

DeviceMara Water Vapor Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantCooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS028 Date Received12/21/2022 Decision Date01/19/2023 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-21
Decision Date2023-01-19
PMAP160047
SupplementS028
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCooperSurgical, Inc.
95 Corporate Drive
trumbull, CT 06611 PMA NumberP160047 Supplement NumberS028 Date Received12/21/2022 Decision Date01/19/2023 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change To The Manufacturer And Manufacturing Of The Sleeve Cartridge Sub-Assembly, Outflow Tube Sub-Assembly, And Syringe Sub-Assembly To Reduce Manufacturing Yield Loss

Supplemental Filings

Supplement NumberDateSupplement Type
P160047Original Filing
S028 2022-12-21 30-day Notice
S027 2022-11-14 30-day Notice
S026 2022-01-05 30-day Notice
S025 2021-09-28 30-day Notice
S024 2021-04-01 30-day Notice
S023 2021-03-25 30-day Notice
S022 2021-03-23 30-day Notice
S021
S020 2021-01-06 30-day Notice
S019 2020-12-22 30-day Notice
S018
S017 2020-10-01 30-day Notice
S016 2020-10-01 30-day Notice
S015 2020-09-29 30-day Notice
S014 2020-09-25 30-day Notice
S013 2020-07-06 Real-time Process
S012 2020-06-22 30-day Notice
S011 2020-06-05 30-day Notice
S010 2020-04-07 30-day Notice
S009
S008
S007 2019-10-10 Normal 180 Day Track No User Fee
S006
S005
S004 2018-12-18 Normal 180 Day Track No User Fee
S003 2018-08-31 Normal 180 Day Track
S002 2018-08-27 30-day Notice
S001 2018-03-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00888937026887 P160047 000
00888937026870 P160047 000
00857379006030 P160047 006
00857379006023 P160047 006

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