|
Device | GYNECARE THERMACHOICE III 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 | S030 |
Date Received | 10/25/2010 |
Decision Date | 06/13/2011 |
Withdrawal Date
|
10/25/2016 |
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 CHANGES TO THE CATHETER BALLOON MEASUREMENT PROCESS. |