PMA P870018S017

Device
LITHOSTAR MULTILINE
Applicant
Siemens Corp.
PMA number
P870018
Supplement
S017
Product code
LNS
Decision date
1998-08-26
Generic name
Lithotriptor, extracorporeal shock-wave, urological
Approval order statement
Approval for a new configuration of the Lithostar(R). The device, as modified, will be marketed under the trade name Lithostar(R) Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.

Current openFDA PMA Record#

Device
LITHOSTAR MULTILINE
Applicant
Siemens Corp.
PMA number
P870018
Supplement
S017
Product code
LNS
Generic name
Lithotriptor, extracorporeal shock-wave, urological
Decision date
1998-08-26
Decision code
APRL
Date received
1997-06-17
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new configuration of the Lithostar(R). The device, as modified, will be marketed under the trade name Lithostar(R) Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.