ECONOLITH(TM) LITHOTRIPTER

FDA Premarket Approval P950043 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

Approval for a transportable version of the econolith(tm) lithotripter.

DeviceECONOLITH(TM) LITHOTRIPTER
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantMEDISPEC, LTD.
Date Received1997-06-25
Decision Date1997-06-30
PMAP950043
SupplementS001
Product CodeLNS 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.