PMA P000032S011

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S011
Product code: MNB
Decision date: 2005-06-30
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: USE OF MECHANICAL CRIMPING, INSTEAD OF SOLDERING, TO FORM A JOINT THAT CONNECTS A CAPILLARY TUBE TO A COMPRESSOR CIRCUIT OF THE CRYOSTAT SUBASSEMBLY.

Current openFDA PMA Record#

Device: HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P000032
Supplement: S011
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2005-06-30
Decision code: OK30
Date received: 2005-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF MECHANICAL CRIMPING, INSTEAD OF SOLDERING, TO FORM A JOINT THAT CONNECTS A CAPILLARY TUBE TO A COMPRESSOR CIRCUIT OF THE CRYOSTAT SUBASSEMBLY.