THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM
FDA premarket approval P970021/S002 · decided 1999-11-02
Approval details
- PMA number
- P970021
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 1999-02-03
- Decision date
- 1999-11-02
- Days to decision
- 272 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- Approval for the following modifications: 1) change in balloon material from latex to silicone; 2) addition of fluid circulation mechanism (i.e., impeller) within catheter; 3) change in software language from Assembly to a combination of C and Assembly; and 4) other minor modifications to the device system. In addition, changes also include a change in the manufacturer of the catheter controller to RELA, Inc., located at 410 S. Sunset, Bldg., D., Longmont, CO 80501. The device is intended for th
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |