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 | 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 | S010 |
Date Received | 11/18/2003 |
Decision Date | 12/02/2003 |
Withdrawal Date
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10/25/2016 |
Product Code |
MKN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS. |
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