PMA P840008S031

Device
DORNIER LITHOTRIPTER MODEL MFL 5000
Applicant
Dornier Medtech America, Inc.
PMA number
P840008
Supplement
S031
Product code
LNS
Decision date
1991-12-20
Classification
Lithotriptor, Extracorporeal Shock-wave, Urological
Generic name
Lithotriptor, extracorporeal shock-wave, urological

Current openFDA PMA Record#

Device
DORNIER LITHOTRIPTER MODEL MFL 5000
Applicant
Dornier Medtech America, Inc.
PMA number
P840008
Supplement
S031
Product code
LNS
Generic name
Lithotriptor, extracorporeal shock-wave, urological
Decision date
1991-12-20
Decision code
APRL
Date received
1991-07-12
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename