ECONOLITH(TM) LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P950043

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

Approval for the econlith(tm) extracorporeal shock wave lithotripter. The device is indicated for use in the non-invasive fragmentation of upper urinary tract stones between 5 and 20mm in size

DeviceECONOLITH(TM) LITHOTRIPTER
Classification NameLithotriptor, Extracorporeal Shock-wave, Urological
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantMEDISPEC, LTD.
Date Received1995-12-26
Decision Date1997-04-07
Notice Date1997-07-10
PMAP950043
SupplementS
Product CodeLNS
Docket Number97M-0253
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address MEDISPEC, LTD. 19110 Montgomery Village Ave. suite 100 montgomery Village, MD 20886

Supplemental Filings

Supplement NumberDateSupplement Type
P950043Original Filing
S006 1999-05-19 Normal 180 Day Track
S005 1998-07-20 Normal 180 Day Track
S004 1998-05-15 Real-time Process
S003
S002 1998-04-06 Real-time Process
S001 1997-06-25 Real-time Process

NIH GUDID Devices

Device IDPMASupp
07290016498257 P950043 006
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