NovaSure Impedance Controlled Endometrial Ablation System
FDA premarket approval P010013/S083 · decided 2021-03-30
Approval details
- PMA number
- P010013
- Supplement
- S083
- 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
- 2021-03-29
- Decision date
- 2021-03-30
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Consolidation of inspection test steps to reduce any over-manipulation of the devices in the manufacturing process and modification of the current inspection sampling method for the Array Liner and Array Sewing Assembly of the NovaSure Gen 4.1 devices from a defined sampling size to a credit sampling method.
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