PMA P840008S063

Device: DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Applicant: Dornier Medtech America, Inc.
PMA number: P840008
Supplement: S063
Product code: LNS
Decision date: 1998-06-19
Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for revision of labeling regarding: 1) the risk of hypertension folloiwng renal lithotripsy, consistent with the conclusions of final postapproval study report (all models) 2) the maximum patient weight to be treated (HM4); and 3) additional safe treatment practices regarding non-ECG gated treatment (MFL 5000).

Current openFDA PMA Record#

Device: DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Applicant: Dornier Medtech America, Inc.
PMA number: P840008
Supplement: S063
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-06-19
Decision code: APRL
Date received: 1998-05-18
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revision of labeling regarding: 1) the risk of hypertension folloiwng renal lithotripsy, consistent with the conclusions of final postapproval study report (all models) 2) the maximum patient weight to be treated (HM4); and 3) additional safe treatment practices regarding non-ECG gated treatment (MFL 5000).