PMA P870015S031

Device
MEDSTONE STS-T LITHOTRIPTER
Applicant
Medstone Intl., Inc.
PMA number
P870015
Supplement
S031
Product code
LNS
Decision date
1999-03-11
Classification
Lithotriptor, Extracorporeal Shock-wave, Urological
Generic name
Lithotriptor, extracorporeal shock-wave, urological
Approval order statement
Approval for minor software upgrades to version 1999.0, minor hardware changes, and associated changes to the device labeling.

Current openFDA PMA Record#

Device
MEDSTONE STS-T LITHOTRIPTER
Applicant
Medstone Intl., Inc.
PMA number
P870015
Supplement
S031
Product code
LNS
Generic name
Lithotriptor, extracorporeal shock-wave, urological
Decision date
1999-03-11
Decision code
APRL
Date received
1999-03-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor software upgrades to version 1999.0, minor hardware changes, and associated changes to the device labeling.