THERASONIC LITHOTRIPSY TREATMENT SYSTEM

FDA Premarket Approval P890066 S004

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

DeviceTHERASONIC LITHOTRIPSY TREATMENT SYSTEM
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantFOCUS SURGERY, INC.
Date Received1992-03-10
Decision Date1992-03-26
PMAP890066
SupplementS004
Product CodeLNS 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address FOCUS SURGERY, INC. 1565 Barber Ln. milpitas, CA 95035

Supplemental Filings

Supplement NumberDateSupplement Type
P890066Original Filing
S005 1994-02-15 Normal 180 Day Track
S004 1992-03-10 Normal 180 Day Track
S003 1991-11-19 Normal 180 Day Track
S002
S001 1991-10-24 Normal 180 Day Track

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