GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
FDA premarket approval P970021/S023 · decided 2008-09-19
Approval details
- PMA number
- P970021
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 2008-08-21
- Decision date
- 2008-09-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- USE OF AN ADDITIONAL STERILIZATION CHAMBER, WHICH IS LOCATED IN THE CURRENTLY APPROVED MANUFACTURING FACILITY.
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 |