LITHOSTAR

FDA Premarket Approval P870018

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceLITHOSTAR
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantSIEMENS CORP.
Date Received1987-04-28
Decision Date1988-09-30
Notice Date1988-11-30
PMAP870018
SupplementS
Product CodeLNS 
Docket Number88M-0363
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS CORP. 186 Wood Ave., South iselin, NJ 08830

Supplemental Filings

Supplement NumberDateSupplement Type
P870018Original Filing
S025 2000-07-10 Real-time Process
S024 2000-04-10 Real-time Process
S023 1999-02-12 Normal 180 Day Track
S022 1999-01-12 Real-time Process
S021 1998-05-01 Normal 180 Day Track
S020
S019 1997-12-11 Special (immediate Track)
S018
S017 1997-06-17 Normal 180 Day Track
S016 1996-05-20 Normal 180 Day Track
S015 1996-04-11 Normal 180 Day Track
S014 1996-03-13 Normal 180 Day Track
S013 1996-02-23 Normal 180 Day Track
S012
S011 1995-09-05 Normal 180 Day Track
S010 1995-05-08 Normal 180 Day Track
S009 1994-02-18 Normal 180 Day Track
S008 1994-02-07 Normal 180 Day Track
S007 1992-06-17 Normal 180 Day Track
S006 1992-01-29 Normal 180 Day Track
S005 1991-10-02 Normal 180 Day Track
S004 1990-12-07 Normal 180 Day Track
S003 1990-11-15 Normal 180 Day Track
S002 1989-04-12 Normal 180 Day Track
S001 1988-12-23 Normal 180 Day Track

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