|
Device | HER OPTION CRYOABLATION THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | CooperSurgical, Inc. 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | P000032 |
Supplement Number | S005 |
Date Received | 01/20/2004 |
Decision Date | 11/09/2004 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |