NovaSure Impedance Controlled Endometrial Ablation System
FDA premarket approval P010013/S072 · decided 2019-01-09
Approval details
- PMA number
- P010013
- Supplement
- S072
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NovaSure Impedance Controlled Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2018-08-23
- Decision date
- 2019-01-09
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for the addition of a second supplier for the gold-plated yarn material used in the Bipolar Electrode Mesh Array of the NovaSure Impedance Controlled Endometrial Ablation System.
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