PMA P000032S022

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S022
Product code: MNB
Decision date: 2008-03-21
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE THE POST STERILE AUDIT TEST PROCESS FOR THE HER OPTION CRYOABLATION SYSTEM DISPOSABLE PROBE.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S022
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2008-03-21
Decision code: APPR
Date received: 2007-10-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE THE POST STERILE AUDIT TEST PROCESS FOR THE HER OPTION CRYOABLATION SYSTEM DISPOSABLE PROBE.