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. |
|
Device | HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | CooperSurgical, Inc. 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | P000032 |
Supplement Number | S030 |
Date Received | 11/23/2009 |
Decision Date | 01/20/2010 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE REFRIGERANT BLEND USED IN THE GAS MIX COMPRESSOR (GMC) OF THE HER OPTION CONSOLE. |
|
|