PMA P970019S004

Device: LITHOTRON ULTRA LITHOSTRIPSY SYSTEM
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S004
Product code: LNS
Decision date: 1998-09-11
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for the following modifications to the LithoTron(TM) Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

Current openFDA PMA Record#

Device: LITHOTRON ULTRA LITHOSTRIPSY SYSTEM
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S004
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-09-11
Decision code: APRL
Date received: 1998-08-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following modifications to the LithoTron(TM) Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.