HER OPTION CYROABLATION THERAPY SYSTEM
FDA premarket approval P000032/S013 · decided 2006-07-03
Approval details
- PMA number
- P000032
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER OPTION CYROABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2005-08-13
- Decision date
- 2006-07-03
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR: 1) UPDATES TO THE SOFTWARE, I.E., IN-ICE DETECTION; 2) IMPROVEMENT IN THE LOCKING TABS; AND 3) LABELING CHANGES.
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