NovaSure Impedance Controlled Endometrial Ablation System
FDA premarket approval P010013/S085 · decided 2022-01-04
Approval details
- PMA number
- P010013
- Supplement
- S085
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- NovaSure Impedance Controlled Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2021-10-04
- Decision date
- 2022-01-04
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for a revision to the NovaSure post approval study protocol, S0112003.
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