|
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 | S003 |
Date Received | 04/24/2003 |
Decision Date | 08/08/2003 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EARLY TERMINATION OF THE CLINICAL TECHNIQUE STANDARDIZATION POST-APPROVAL STUDY. |