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. |
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Device | 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 | S006 |
Date Received | 11/08/2002 |
Decision Date | 05/07/2003 |
Withdrawal Date
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10/25/2016 |
Product Code |
MKN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MATERIAL CHANGE TO THE SILIXONE BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM. |
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