PMA P970021S010
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S010
- Product code
- MKN
- Decision date
- 2003-12-02
- Classification
- Catheter, Balloon, Transcervical
- Generic name
- Catheter, balloon, transcervical
- Approval order statement
- APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S010
- Product code
- MKN
- Generic name
- Catheter, balloon, transcervical
- Decision date
- 2003-12-02
- Decision code
- APPR
- Date received
- 2003-11-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS.