PMA P000032S021

Device
HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant
CooperSurgical, Inc.
PMA number
P000032
Supplement
S021
Product code
MNB
Decision date
2007-07-27
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.

Current openFDA PMA Record#

Device
HER OPTION CRYOABLATION THERAPY SYSTEM
Applicant
CooperSurgical, Inc.
PMA number
P000032
Supplement
S021
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2007-07-27
Decision code
OK30
Date received
2007-06-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.