ECONOLITH(TM) LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P950043 S004

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 minor labeling and hardware changes.

• Device: ECONOLITH(TM) LITHOTRIPTER
• Classification Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Generic Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: MEDISPEC, LTD.
• Date Received: 1998-05-15
• Decision Date: 1998-05-21
• PMA: P950043
• Supplement: S004
• Product Code: LNS
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• 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