Mara Vapor System
FDA premarket approval P160047/S014 · decided 2020-10-20
Approval details
- PMA number
- P160047
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mara Vapor System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2020-09-25
- Decision date
- 2020-10-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Changes in manufacturing to reduce the amount of copper on the printed circuit board assembly (PCBA). These include a reduction in the amount of copper around the solder hole for the ground pin of the PCBA-mounted pressure sensor and around non-plater thru holes (NPTH).
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