PMA P000032S025

Device: HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S025
Product code: MNB
Decision date: 2008-07-16
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES.

Current openFDA PMA Record#

Device: HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S025
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2008-07-16
Decision code: APPR
Date received: 2008-02-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES.