AEGEA Vapor System
FDA premarket approval P160047/S002 · decided 2018-09-25
Approval details
- PMA number
- P160047
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AEGEA Vapor System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2018-08-27
- Decision date
- 2018-09-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Change of manufacturing site where the raw materials are purchased, received, inspected, and stored.
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