HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S005 · decided 2004-11-09
Approval details
- PMA number
- P000032
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2004-01-20
- Decision date
- 2004-11-09
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A REVISED USER'S MANUAL AND PACKAGE INSERT WHICH REFLECTS THE RESULTS OF THE LONG TERM FOLLOW-UP OF STUDY SUBJECTS AND A QUICK REFERENCE GUIDE.
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