PMA P870015S027

Device: MEDSTONE STS(TM) LITHOTRIPTER
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S027
Product code: LNS
Decision date: 1997-10-31
Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
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: MEDSTONE STS(TM) LITHOTRIPTER
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S027
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1997-10-31
Decision code: APRL
Date received: 1997-10-06
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).