Mara Water Vapor Ablation System
FDA premarket approval P160047/S008 · decided 2020-06-17
Approval details
- PMA number
- P160047
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mara Water Vapor Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2020-03-20
- Decision date
- 2020-06-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for software changes to fix known anomalies identified in P160047/ S006 and to include device-specific user authentication.
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