EDAP LT.01 SHOCK WAVE LITHOTRIPTER

FDA Premarket Approval P880042

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

DeviceEDAP LT.01 SHOCK WAVE LITHOTRIPTER
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantEDAP INTERNATIONAL CORP.
Date Received1988-06-02
Decision Date1991-12-12
Notice Date1992-01-15
PMAP880042
SupplementS
Product CodeLNS 
Docket Number91M-0507
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address EDAP INTERNATIONAL CORP. 179 Sidney St. cambridge, MA 02139

Supplemental Filings

Supplement NumberDateSupplement Type
P880042Original Filing
S002 1995-05-19 Normal 180 Day Track
S001 1994-02-14 Normal 180 Day Track

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