SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Premarket Approval P880062 S001

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.

Pre-market Approval Supplement Details

DeviceSONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
Classification NameApplicator, Hyperthermia, Deep Heating, Ultrasound
Generic NameApplicator, Hyperthermia, Deep Heating, Ultrasound
ApplicantLABTHERMICS TECHNOLOGIES, INC.
Date Received1990-05-17
Decision Date1990-08-23
PMAP880062
SupplementS001
Product CodeLNB
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address LABTHERMICS TECHNOLOGIES, INC. 701 Devonshire Dr., Bldg. B-1 champaign, IL 61820

Supplemental Filings

Supplement NumberDateSupplement Type
P880062Original Filing
S002 1996-12-16 Normal 180 Day Track
S001 1990-05-17 Normal 180 Day Track
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