PMA P000032S005

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S005
Product code: MNB
Decision date: 2004-11-09
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A REVISED USER'S MANUAL AND PACKAGE INSERT WHICH REFLECTS THE RESULTS OF THE LONG TERM FOLLOW-UP OF STUDY SUBJECTS AND A QUICK REFERENCE GUIDE.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S005
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2004-11-09
Decision code: APPR
Date received: 2004-01-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REVISED USER'S MANUAL AND PACKAGE INSERT WHICH REFLECTS THE RESULTS OF THE LONG TERM FOLLOW-UP OF STUDY SUBJECTS AND A QUICK REFERENCE GUIDE.