HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S033 · decided 2010-09-22
Approval details
- PMA number
- P000032
- Supplement
- S033
- Supplement type
- 135 Review Track For 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
- 2010-01-22
- Decision date
- 2010-09-22
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A CHANGE TO THE INCOMING MEASUREMENT METHOD.
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