|
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 | S017 |
Date Received | 01/17/2006 |
Decision Date | 02/16/2006 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR. |