GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM
FDA premarket approval P970021/S037 · decided 2013-04-03
Approval details
- PMA number
- P970021
- Supplement
- S037
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Gynecare, Inc.
- Date received
- 2012-02-23
- Decision date
- 2013-04-03
- Days to decision
- 405 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR A CHANGE IN THE RESIN SUPPLIER FOR THE THERMACHOICE 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 |