HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S022 · decided 2008-03-21
Approval details
- PMA number
- P000032
- Supplement
- S022
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2007-10-17
- Decision date
- 2008-03-21
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE THE POST STERILE AUDIT TEST PROCESS FOR THE HER OPTION CRYOABLATION SYSTEM DISPOSABLE PROBE.
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