HTA SYSTEM
FDA premarket approval P000040/S010 · decided 2007-08-08
Approval details
- PMA number
- P000040
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2007-03-29
- Decision date
- 2007-08-08
- Days to decision
- 132 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 NEXCORE TECHNOLOGY, INC., WALDWICK, NEW JERSEY TO MANUFACTURE THE FOLLOWING COMPONENTS: HTA SYSTEM CONSOLE, REUSABLE HEATER CANISTER, AND SCOPE ADAPTER.
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