THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
FDA premarket approval P970021 · decided 1997-12-12
Approval details
- PMA number
- P970021
- Trade name
- THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 1997-06-17
- Decision date
- 1997-12-12
- Days to decision
- 178 days
- Decision code
- APWD
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- Approval for the ThermaChoice(TM) Uterine Balloon Therapy(TM) UBT System. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.
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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 |