Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | GYNECARE THERMACHOICE 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 | S007 |
Date Received | 01/13/2003 |
Decision Date | 03/27/2003 |
Withdrawal Date
|
10/25/2016 |
Product Code |
MKN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY. |
|
|