PMA P970021S004

Device: THERMA CHOICE UTERINE BALLON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S004
Product code: MNB
Decision date: 2001-02-13
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL TO TRANSFER THE THERMACHOICE CATHETER MANUFACTURING OPERATIONS TO A NEW MANUFACTURING FACILITY LOCATED AT ETHICON, INC., CHIHUAHUA, MEXICO.

Current openFDA PMA Record#

Device: THERMA CHOICE UTERINE BALLON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S004
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2001-02-13
Decision code: APPR
Date received: 2000-08-07
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO TRANSFER THE THERMACHOICE CATHETER MANUFACTURING OPERATIONS TO A NEW MANUFACTURING FACILITY LOCATED AT ETHICON, INC., CHIHUAHUA, MEXICO.