PMA P870018S019

Device: LITHOSTAR MULTILINE
Applicant: Siemens Corp.
PMA number: P870018
Supplement: S019
Product code: LNS
Decision date: 1997-12-29
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).

Current openFDA PMA Record#

Device: LITHOSTAR MULTILINE
Applicant: Siemens Corp.
PMA number: P870018
Supplement: S019
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1997-12-29
Decision code: APRL
Date received: 1997-12-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).