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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHER OPTION CRYOABLATION THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP000032
Supplement NumberS005
Date Received01/20/2004
Decision Date11/09/2004
Withdrawal Date 09/07/2023
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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