SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Premarket Approval P880062

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

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 Received1988-08-08
Decision Date1989-09-29
Notice Date1989-11-14
PMAP880062
SupplementS
Product CodeLNB
Docket Number89M-0449
Advisory CommitteeRadiology
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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