NovaSure Impedance Controlled Endometrial Ablation System
FDA premarket approval P010013/S090 · decided 2023-09-22
Approval details
- PMA number
- P010013
- Supplement
- S090
- Supplement type
- 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
- 2023-09-22
- Decision date
- 2023-09-22
- Days to decision
- 0 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Changes in sterilization parameters at the approved sterilization site Steris Costa Rica.
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