DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P840008 S061

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 to offer the dornier x-ray imaging module, the extended image stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the advance technology laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by fda after our review of your postapproval study results.

DeviceDORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Classification NameLithotriptor, Extracorporeal Shock-wave, Urological
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantDornier MedTech America, Inc.
Date Received1997-10-21
Decision Date1997-11-03
PMAP840008
SupplementS061
Product CodeLNS
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
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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