EDAP LT.01 SHOCK WAVE LITHOTRIPTER

FDA Premarket Approval P880042 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

DeviceEDAP LT.01 SHOCK WAVE LITHOTRIPTER
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantEDAP INTERNATIONAL CORP.
Date Received1994-02-14
Decision Date1994-04-18
PMAP880042
SupplementS001
Product CodeLNS 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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