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.
| Device | Mara Water Vapor Ablation System |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | CooperSurgical, 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 Received | 2022-12-21 |
| Decision Date | 2023-01-19 |
| PMA | P160047 |
| Supplement | S028 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperSurgical, 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160047 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00888937026887 | P160047 | 000 |
| 00888937026870 | P160047 | 000 |
| 00857379006030 | P160047 | 006 |
| 00857379006023 | P160047 | 006 |