Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta
FDA premarket approval P000040/S035 · decided 2017-06-29
Approval details
- PMA number
- P000040
- Supplement
- S035
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2017-04-11
- Decision date
- 2017-06-29
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a manufacturing site located at Boston Scientific Corporation, 150 Baytech Drive, San Jose, California.
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