TRANSMOBILE LITHOSTAR MODULARIS

FDA Premarket Approval P870018 S022

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 transportable (between hospitals) lithostar modularis.

DeviceTRANSMOBILE LITHOSTAR MODULARIS
Generic NameLithotriptor, Extracorporeal Shock-wave, Urological
ApplicantSIEMENS CORP.
Date Received1999-01-12
Decision Date1999-01-21
PMAP870018
SupplementS022
Product CodeLNS 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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