MARA Water Vapor System
FDA premarket approval P160047/S005 · decided 2020-01-08
Approval details
- PMA number
- P160047
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MARA Water Vapor System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2019-06-19
- Decision date
- 2020-01-08
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval of changes to the instructions for use and patient labeling to include the results of the Post-Ablation Cavity Evaluation (PACE) study, which evaluated the ability to assess the uterine cavity more than three-years post endometrial ablation with the MARA Water Vapor System
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