ECONOLITH(TM) LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P950043 S002

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

Approval for non-synchronized eswl, addition of a ecg simulator/adapter, and appropriate labeling revisions.

DeviceECONOLITH(TM) LITHOTRIPTER
Classification NameLithotriptor, Extracorporeal Shock-wave, Urological
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantMEDISPEC, LTD.
Date Received1998-04-06
Decision Date1998-05-05
PMAP950043
SupplementS002
Product CodeLNS
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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