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 | TMX-2000 BPH |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000043 |
Supplement Number | S009 |
Date Received | 09/17/2004 |
Decision Date | 10/18/2004 |
Withdrawal Date
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12/20/2016 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
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 MANUFACTURING SITE AT AMERICAN MEDICAL SYSTEMS (AMS), MINNETONKA, MINNESOTA. AMS WILL DUPLICATE MANUFACTURE THE TEMPERATURE SENSOR AND REFERENCE PROBE AND CONDUCT LAPTOP IMAGING AND CONSOLE BURN-IN. |
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