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 UTERINE BALLOON THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | GYNECARE, INC. P.O. BOX 151 SOMMERVILLE, NJ 08876-0151 |
PMA Number | P970021 |
Supplement Number | S005 |
Date Received | 08/28/2000 |
Decision Date | 10/19/2001 |
Withdrawal Date
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10/25/2016 |
Product Code |
MNB |
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 TO RELOCATE DEVICE MANUFACTURING DUE TO THE CLOSURE OF THE GYNECARE MENLO PARK FACILITY. MANUFACTURING WILL BE PERFORMED AT RELA/COLORADO MEDTECH, INC, LONGMONT, COLORADO AND AT ETHICON, INC., SOMERVILE, NEW JERSEY. |
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