PMA P870015S025

Device: MEDSTONE STS(TM) LITHOTRIPTER
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S025
Product code: LNS
Decision date: 1996-11-18
Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: USE OF THE PHYSICIAN'S REFERENCE GUIDE ENTITLED "PHYSICIAN'S REFERENCE GUIDE FOR THE MEDSTONE STS(R) SHOCK WAVE THERAPY SYSTEM"

Current openFDA PMA Record#

Device: MEDSTONE STS(TM) LITHOTRIPTER
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S025
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1996-11-18
Decision code: APRL
Date received: 1996-10-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: USE OF THE PHYSICIAN'S REFERENCE GUIDE ENTITLED "PHYSICIAN'S REFERENCE GUIDE FOR THE MEDSTONE STS(R) SHOCK WAVE THERAPY SYSTEM"