PMA P970021S042

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S042
Product code: MNB
Decision date: 2014-12-04
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: MANUFACTURING CHANGES TO THE GYNECARE THERMACHOICE II CONTROLLER TO MEET AND COMPLY WITH THE EUROPEAN RESTRICTION OF HAZARDOUS SUBSTANCES (ROHS) DIRECTIVE2011/65/EU BY REPLACING NON-ROHS COMPLIANT COMPONENTS WITH FUNCTIONALLY EQUIVALENT ROHS COMPLIANT COMPONENTS.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S042
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2014-12-04
Decision code: OK30
Date received: 2014-11-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING CHANGES TO THE GYNECARE THERMACHOICE II CONTROLLER TO MEET AND COMPLY WITH THE EUROPEAN RESTRICTION OF HAZARDOUS SUBSTANCES (ROHS) DIRECTIVE2011/65/EU BY REPLACING NON-ROHS COMPLIANT COMPONENTS WITH FUNCTIONALLY EQUIVALENT ROHS COMPLIANT COMPONENTS.