DORNIER LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P840008 S050

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a new model lithotripter trade name:dornier lithotripter

DeviceDORNIER LITHOTRIPTER
Classification NameLithotriptor, Extracorporeal Shock-wave, Urological
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantDornier MedTech America, Inc.
Date Received1995-02-28
Decision Date1995-08-21
PMAP840008
SupplementS050
Product CodeLNS
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Dornier MedTech America, Inc. 1155 Roberts Blvd. kennesaw, GA 30144

Supplemental Filings

Supplement NumberDateSupplement Type
P840008Original Filing
S069 1999-08-20 Real-time Process
S068 1999-02-24 Real-time Process
S067 1999-02-02 Normal 180 Day Track
S066 1998-07-28 Real-time Process
S065 1998-06-25 Real-time Process
S064 1998-05-26 Real-time Process
S063 1998-05-18 Special (immediate Track)
S062 1998-02-25 Normal 180 Day Track
S061 1997-10-21 Real-time Process
S060 1996-12-16 Real-time Process
S059 1996-12-16 Real-time Process
S058 1996-12-09 Normal 180 Day Track
S057 1996-11-01 Normal 180 Day Track
S056 1996-07-01 Normal 180 Day Track
S055
S054 1996-03-22 Normal 180 Day Track
S053 1995-12-04 Normal 180 Day Track
S052 1995-08-09 Normal 180 Day Track
S051 1995-05-01 Normal 180 Day Track
S050 1995-02-28 Normal 180 Day Track
S049 1994-06-08 Normal 180 Day Track
S048 1994-04-18 Normal 180 Day Track
S047 1993-08-09 Normal 180 Day Track
S046 1993-07-19 Normal 180 Day Track
S045 1993-03-11 Normal 180 Day Track
S044 1993-02-22 Normal 180 Day Track
S043
S042 1992-07-07 Normal 180 Day Track
S041 1992-06-26 Normal 180 Day Track
S040 1992-05-11 Panel Track
S039 1992-05-04 Normal 180 Day Track
S038 1992-04-09 Normal 180 Day Track
S037 1992-02-03 Normal 180 Day Track
S036
S035 1991-10-08 Normal 180 Day Track
S034 1991-09-30 Normal 180 Day Track
S033 1991-09-11 Normal 180 Day Track
S032 1991-08-26 Normal 180 Day Track
S031 1991-07-12 Normal 180 Day Track
S030 1991-06-21 Normal 180 Day Track
S029 1991-05-24 Normal 180 Day Track
S028 1991-03-11 Normal 180 Day Track
S027 1991-01-09 Normal 180 Day Track
S026 1990-05-21 Panel Track
S025 1990-09-14 Normal 180 Day Track
S024 1990-06-18 Normal 180 Day Track
S023 1990-02-08 Normal 180 Day Track
S022
S021 1989-05-03 Normal 180 Day Track
S020
S019 1988-05-09 30-Day Supplement
S018 1987-10-05 Normal 180 Day Track
S017
S016 1987-09-15 Normal 180 Day Track
S015 1987-07-10 Normal 180 Day Track
S014 1987-06-23 Normal 180 Day Track
S013 1987-06-12 Normal 180 Day Track
S012 1987-05-19 Normal 180 Day Track
S011 1987-04-13 Normal 180 Day Track
S010 1987-03-19 Normal 180 Day Track
S009 1986-12-12 Normal 180 Day Track
S008 1986-09-09 Normal 180 Day Track
S007 1986-07-03 Normal 180 Day Track
S006 1986-06-19 Normal 180 Day Track
S005 1986-06-10 Special (immediate Track)
S004 1986-02-28 Normal 180 Day Track
S003 1985-12-24 Normal 180 Day Track
S002 1985-11-22 Normal 180 Day Track
S001 1985-10-31 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04049957000714 P840008 069
04049957000578 P840008 069
04049957000561 P840008 069
04049957000554 P840008 069
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