GENESYS HTA SYSTEM
FDA premarket approval P000040/S027 · decided 2013-05-16
Approval details
- PMA number
- P000040
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2012-12-05
- Decision date
- 2013-05-16
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN SPENCER, INDIANA, AND BOSTON SCIENTIFIC CORPORATION, IN COVENTRY, RHODE ISLAND.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.