GENESYS HTA SYSTEM
FDA premarket approval P000040/S016 · decided 2010-07-08
Approval details
- PMA number
- P000040
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2010-06-14
- Decision date
- 2010-07-08
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- IMPLEMENTATION OF AN INSPECTION AT THE CASSETTE MANUFACTURER AND AN UPDATE TO A SUBASSEMBLY DRAWING.
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