|
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 | S032 |
Date Received | 01/21/2010 |
Decision Date | 09/02/2010 |
Withdrawal Date
|
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 A CHANGE TO THE CONSOLE TESTING METHOD. |