MARA Water Vapor Ablation System
FDA premarket approval P160047/S033 · decided 2023-10-25
Approval details
- PMA number
- P160047
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARA Water Vapor Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2023-09-26
- Decision date
- 2023-10-25
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for a modification to the manufacturing process to increase reproducibility of the coil subassembly, balloon subassembly, and MLE subassembly and tail cuts.
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|---|---|---|
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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 |
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| Wallace Dual Lumen Oocyte Recovery System (K191291) | CooperSurgical, Inc. | 2019-06-12 |
| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |