GENESYS HTA SYSTEM
FDA premarket approval P000040/S021 · decided 2012-04-23
Approval details
- PMA number
- P000040
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2011-12-23
- Decision date
- 2012-04-23
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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