|
Device | GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | GYNECARE, INC. P.O. BOX 151 SOMMERVILLE, NJ 08876-0151 |
PMA Number | P970021 |
Supplement Number | S037 |
Date Received | 02/23/2012 |
Decision Date | 04/03/2013 |
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 A CHANGE IN THE RESIN SUPPLIER FOR THE THERMACHOICE BALLOON. |