GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
FDA premarket approval P970021/S040 · decided 2014-03-17
Approval details
- PMA number
- P970021
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 2013-12-18
- Decision date
- 2014-03-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR A CHANGE TO THE HEATER WIRE SHRINK TUBING WITHIN THE BALLOON.
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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 |