MARA Water Vapor Ablation System
FDA premarket approval P160047/S035 · decided 2024-07-11
Approval details
- PMA number
- P160047
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARA Water Vapor Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2024-01-23
- Decision date
- 2024-07-11
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for the changes in the manufacturing process for the MARA water vapor probe to include the addition of silicone lubricant on the inside diameter of the tip cover.
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510(k) clearances by this applicant
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|---|---|---|
| Fetal Pillow (K243799) | CooperSurgical, Inc. | 2025-08-29 |
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| ALLY II Uterine Positioning System™ (UPS) (K223064) | CooperSurgical, Inc. | 2022-10-28 |
| Advincula Delineator Uterine Manipulator (K201086) | CooperSurgical, Inc. | 2020-05-21 |
| Endosee System (K200038) | CooperSurgical, Inc. | 2020-02-05 |
| G210 InviCell Plus with SignipHy pH monitoring (K191020) | CooperSurgical, Inc. | 2020-01-14 |
| Wallace Dual Lumen Oocyte Recovery System (K191291) | CooperSurgical, Inc. | 2019-06-12 |
| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |