PMA P970021S003

Device: THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S003
Product code: MNB
Decision date: 2000-08-14
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR REVISED LABELING THAT INCLUDES THREE-YEAR POST-TREATMENT INFORMATION, AS REQUIRED AS A CONDITION OF APPROVAL FOR THE ORIGINAL PMA APPLICATION.

Current openFDA PMA Record#

Device: THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S003
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2000-08-14
Decision code: APPR
Date received: 2000-03-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED LABELING THAT INCLUDES THREE-YEAR POST-TREATMENT INFORMATION, AS REQUIRED AS A CONDITION OF APPROVAL FOR THE ORIGINAL PMA APPLICATION.