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

• Device: SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
• Classification Name: Applicator, Hyperthermia, Deep Heating, Ultrasound
• Generic Name: Applicator, Hyperthermia, Deep Heating, Ultrasound
• Applicant: LABTHERMICS TECHNOLOGIES, INC.
• Date Received: 1988-08-08
• Decision Date: 1989-09-29
• Notice Date: 1989-11-14
• PMA: P880062
• Supplement: S
• Product Code: LNB
• Docket Number: 89M-0449
• Advisory Committee: Radiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: LABTHERMICS TECHNOLOGIES, INC. 701 Devonshire Dr., Bldg. B-1 champaign, IL 61820

Supplemental Filings

Supplement Number	Date	Supplement Type
P880062		Original Filing
S002	1996-12-16	Normal 180 Day Track
S001	1990-05-17	Normal 180 Day Track