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 | UROLOGIX TARGIS SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Urologix, LLC 14405 21ST AVENUE N. MINNEAPOLIS, MN 55447-2000 |
PMA Number | P970008 |
Supplement Number | S022 |
Date Received | 07/05/2002 |
Decision Date | 08/01/2002 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE OF SUPPLIER FOR THE FIBER OPTIC TEMPERATURE SENSOR PROBE COMPONENT FROM THE LUXTRON CORPORATION IN SANTA CLARA, CALIFORNIA TO THE UROLOGIX FACILITY AND A CHANGE IN THE USE OF AN ADHESIVE BONDING PROCESS TO AN ANNEALING PROCESS ON THE COOLANT BAG. |
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