GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
FDA premarket approval P970021/S014 · decided 2007-07-06
Approval details
- PMA number
- P970021
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - PAS
- Trade name
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 2007-01-11
- Decision date
- 2007-07-06
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR REVISED PROFESSIONAL LABELING TO INCLUDE THE RESULTS OF A MULTI-CENTER STUDY OF THE GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY (UBT) SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GYNECARE VERSAPOINT G-VAP ELECTRODE (K992901) | Gynecare, Inc. | 2000-01-18 |
| VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) (K982738) | Gynecare, Inc. | 1999-03-01 |
| SCUBA SYSTEM (K962482) | Gynecare, Inc. | 1996-11-01 |