|
Device | GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM |
Generic Name | Catheter, balloon, transcervical |
Applicant | GYNECARE, INC. P.O. BOX 151 SOMMERVILLE, NJ 08876-0151 |
PMA Number | P970021 |
Supplement Number | S012 |
Date Received | 12/17/2004 |
Decision Date | 01/03/2005 |
Withdrawal Date
|
10/25/2016 |
Product Code |
MKN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD. |