PMA P000032S017

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S017
Product code: MNB
Decision date: 2006-02-16
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S017
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2006-02-16
Decision code: APPR
Date received: 2006-01-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR.