HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM
FDA premarket approval P000032/S001 · decided 2001-09-07
Approval details
- PMA number
- P000032
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2001-08-09
- Decision date
- 2001-09-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR REVISIONS TO THE HER OPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM LABELING.
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