PMA P870015S021

Device: MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S021
Product code: LNS
Decision date: 1995-09-15
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS:USE OF ALTERNATE ULTRASOUND IMAGING UNIT; USE OF ALTERNATE DIGITIZER PAD; MODIFICATION OF SYSTEM SOFTWARE TO VERSION 7.10; AND REVISIONS TO SYSTEMS USER'S MANUAL

Current openFDA PMA Record#

Device: MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
Applicant: Medstone Intl., Inc.
PMA number: P870015
Supplement: S021
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1995-09-15
Decision code: APRL
Date received: 1995-07-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS:USE OF ALTERNATE ULTRASOUND IMAGING UNIT; USE OF ALTERNATE DIGITIZER PAD; MODIFICATION OF SYSTEM SOFTWARE TO VERSION 7.10; AND REVISIONS TO SYSTEMS USER'S MANUAL