ECONOLITH LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P950043 S006

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 the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe econolith(tm) lithotripter's labeling to reflect the results of the final report. Based upon the information submitted, fda believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that the postapproval requirement is now complete.

• Device: ECONOLITH LITHOTRIPTER
• Classification Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Generic Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: MEDISPEC, LTD.
• Date Received: 1999-05-19
• Decision Date: 1999-08-27
• PMA: P950043
• Supplement: S006
• Product Code: LNS
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDISPEC, LTD. 19110 Montgomery Village Ave. suite 100 montgomery Village, MD 20886

Supplemental Filings

Supplement Number	Date	Supplement Type
P950043		Original 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 ID	PMA	Supp
07290016498257	P950043	006