PMA P970021S036

Device: GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S036
Product code: MNB
Decision date: 2011-09-23
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A CHANGE IN THE MATERIAL USED TO FORM THE INSULATION LAYER OF THE THERMOCOUPLE WIRES USED WITHIN THE BALLOON OF THE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S036
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2011-09-23
Decision code: APPR
Date received: 2011-08-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE MATERIAL USED TO FORM THE INSULATION LAYER OF THE THERMOCOUPLE WIRES USED WITHIN THE BALLOON OF THE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM.