PMA P870018S021

Device: MODULARIS LITHO
Applicant: Siemens Corp.
PMA number: P870018
Supplement: S021
Product code: LNS
Decision date: 1998-09-21
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for a compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Current openFDA PMA Record#

Device: MODULARIS LITHO
Applicant: Siemens Corp.
PMA number: P870018
Supplement: S021
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-09-21
Decision code: APRL
Date received: 1998-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.