MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit
FDA premarket approval P160047 · decided 2017-06-14
Approval details
- PMA number
- P160047
- Trade name
- MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2016-10-25
- Decision date
- 2017-06-14
- Days to decision
- 232 days
- Decision code
- APWD
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for the AEGEA Vapor System (including the AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, and AEGEA Vapor Generator Accessory Kit). This device is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes in whom childbearing is complete.
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