PMA P000032S037

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S037
Product code: MNB
Decision date: 2011-11-03
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A MANUFACTURING SITES LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNECTICUT AND LONE STAR MEDICAL PRODUCTS IN STAFFORD, TEXAS.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S037
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2011-11-03
Decision code: APPR
Date received: 2011-10-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITES LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNECTICUT AND LONE STAR MEDICAL PRODUCTS IN STAFFORD, TEXAS.