HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S031 · decided 2010-01-07
Approval details
- PMA number
- P000032
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2009-12-11
- Decision date
- 2010-01-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- CHANGE IN THE FINAL TESTER OF THE DEVICE TO BETTER MONITOR TEST RESULTS AS WELL AS CHANGES IN THE TEST METHODS USED IN THE FINAL TESTER.
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