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 | SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM |
Generic Name | Applicator, hyperthermia, deep heating, ultrasound |
Applicant | LABTHERMICS TECHNOLOGIES, INC. 701 DEVONSHIRE DR., BLDG. B-1 CHAMPAIGN, IL 61820 |
PMA Number | P880062 |
Supplement Number | S002 |
Date Received | 12/16/1996 |
Decision Date | 02/13/1997 |
Product Code |
LNB |
Advisory Committee |
Radiology |
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 CHANGES TO THE COMPUTER SYSTEM AND REVISIONS TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000. |
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