PMA P970021S043

Device: GYNECARE THERMACHOICE II BALLOON CATHETER
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S043
Product code: MNB
Decision date: 2015-10-02
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: CHANGES TO THE MANUFACTURING PROCESS, PROCESS SPECIFICATION FOR DRIVE ASSEMBLY, THERMACHOICE CATHETERS 3.0, FOR THE GYNECARE THERMACHOICE BALLOON CATHETER.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE II BALLOON CATHETER
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S043
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2015-10-02
Decision code: OK30
Date received: 2015-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE MANUFACTURING PROCESS, PROCESS SPECIFICATION FOR DRIVE ASSEMBLY, THERMACHOICE CATHETERS 3.0, FOR THE GYNECARE THERMACHOICE BALLOON CATHETER.