MAGNETOM

FDA Premarket Approval P830081 S008

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

DeviceMAGNETOM
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantSIEMENS CORP.
Date Received1986-10-20
Decision Date1987-03-26
PMAP830081
SupplementS008
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
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
P830081Original Filing
S022 1988-07-07 Normal 180 Day Track
S021
S020
S019 1988-06-24 Normal 180 Day Track
S018 1988-03-28 Normal 180 Day Track
S017 1988-03-28 30-Day Supplement
S016 1988-01-20 30-Day Supplement
S015 1987-10-01 Normal 180 Day Track
S014 1987-07-01 Normal 180 Day Track
S013 1987-06-12 Normal 180 Day Track
S012 1987-03-19 Normal 180 Day Track
S011 1987-01-09 Normal 180 Day Track
S010 1986-12-09 Normal 180 Day Track
S009 1986-11-04 Normal 180 Day Track
S008 1986-10-20 Normal 180 Day Track
S007 1986-03-21
S006 1986-01-13
S005 1985-04-25
S004 1985-03-18 Normal 180 Day Track
S003 1985-02-27
S002 1985-01-24
S001 1984-12-07

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