PMA P000032S028

Device: HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S028
Product code: MNB
Decision date: 2009-03-27
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR).

Current openFDA PMA Record#

Device: HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S028
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2009-03-27
Decision code: APPR
Date received: 2008-06-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR).