HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S042 · decided 2014-12-18
Approval details
- PMA number
- P000032
- Supplement
- S042
- 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
- 2014-11-24
- Decision date
- 2014-12-18
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- CHANGE TO THE QUALITY CONTROL HIGH POTENTIAL ELECTRICAL SAFETY ANALYZER FROM ONE DEVICE TO ANOTHER.
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| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |