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 | S025 |
Date Received | 02/06/2008 |
Decision Date | 07/16/2008 |
Withdrawal Date
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09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES. |
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