|
Device | HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | CooperSurgical, Inc. 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | P000032 |
Supplement Number | S028 |
Date Received | 06/06/2008 |
Decision Date | 03/27/2009 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR). |
Post-Approval Study | Show Report Schedule and Study Progress |