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. |
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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 | S038 |
Date Received | 08/23/2012 |
Decision Date | 02/06/2013 |
Withdrawal Date
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09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY. |
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