|
Device | GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | GYNECARE, INC. P.O. BOX 151 SOMMERVILLE, NJ 08876-0151 |
PMA Number | P970021 |
Supplement Number | S036 |
Date Received | 08/03/2011 |
Decision Date | 09/23/2011 |
Withdrawal Date
|
10/25/2016 |
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 IN THE MATERIAL USED TO FORM THE INSULATION LAYER OF THE THERMOCOUPLE WIRES USED WITHIN THE BALLOON OF THE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM. |