PMA P000032S006

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S006
Product code: MNB
Decision date: 2005-03-21
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: ADDITION OF A NEW TYPE OF FILTER TO THE CRYOSTAT, A CHANGE TO ENHANCE THE CORROSION RESISTANCE OF THE CRYOSTAT TUBING AND A CHANGE IN THE CRYOSTAT CLEANING METHOD.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S006
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2005-03-21
Decision code: OK30
Date received: 2005-02-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW TYPE OF FILTER TO THE CRYOSTAT, A CHANGE TO ENHANCE THE CORROSION RESISTANCE OF THE CRYOSTAT TUBING AND A CHANGE IN THE CRYOSTAT CLEANING METHOD.