GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
FDA premarket approval P970021/S007 · decided 2003-03-27
Approval details
- PMA number
- P970021
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Generic name
- Catheter, balloon, transcervical
- Applicant
- Gynecare, Inc.
- Date received
- 2003-01-13
- Decision date
- 2003-03-27
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MKN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS 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 |