HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S009 · decided 2005-05-26
Approval details
- PMA number
- P000032
- Supplement
- S009
- Supplement type
- 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
- 2005-05-02
- Decision date
- 2005-05-26
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- ADDITION OF A NEW TYPE OF FILTER TO THE CRYOSTAT, CHANGE TO ENHANCE THE CORROSION RESISTANCE OF THE CRYOSTAT TUBING, CHANGE IN THE CRYOSTAT CLEANING METHOD.
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