Mara Water Vapor Ablation System
FDA premarket approval P160047/S025 · decided 2021-10-29
Approval details
- PMA number
- P160047
- Supplement
- S025
- Supplement type
- 30-Day Notice
- 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
- 2021-09-28
- Decision date
- 2021-10-29
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Changes made to Mara Water Vapor Probe Handle, Handle Plug, and Protective Sheath Assembly.
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|---|---|---|
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| Endosee System (K200038) | CooperSurgical, Inc. | 2020-02-05 |
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| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |