Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console
FDA premarket approval P160047/S011 · decided 2020-07-01
Approval details
- PMA number
- P160047
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2020-06-05
- Decision date
- 2020-07-01
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Addition of the NRTL label (Nationally Recognized Test Lab label) to the back of the Mara Console.
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