HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S012 · decided 2005-09-21
Approval details
- PMA number
- P000032
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2005-08-04
- Decision date
- 2005-09-21
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A CHANGE IN MATERIAL TO THE PRECOOL FINNED TUBING AND THE MIXED GAS FINNED TUBING FROM 304 STAINLESS STEEL TO INCONEL 625
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