NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000

FDA Premarket Approval P830052 S015

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

DeviceNUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
Date Received1987-12-15
Decision Date1988-05-16
PMAP830052
SupplementS015
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 Miner Rd. cleveland, OH 44143

Supplemental Filings

Supplement NumberDateSupplement Type
P830052Original Filing
S022 1988-07-05 30-Day Supplement
S021 1988-07-05 30-Day Supplement
S020
S019 1988-06-08 Normal 180 Day Track
S018 1988-04-01 30-Day Supplement
S017 1988-03-31 Normal 180 Day Track
S016 1988-02-12 Normal 180 Day Track
S015 1987-12-15 Normal 180 Day Track
S014 1987-11-30 Normal 180 Day Track
S013 1987-11-13 Normal 180 Day Track
S012 1987-11-13 Normal 180 Day Track
S011 1987-07-08 Normal 180 Day Track
S010 1987-06-29 Normal 180 Day Track
S009 1986-12-12 Normal 180 Day Track
S008 1986-08-21 Normal 180 Day Track
S007 1986-05-28 Normal 180 Day Track
S006 1986-02-14 Normal 180 Day Track
S005 1985-08-28 Normal 180 Day Track
S004
S003 1984-10-12 Normal 180 Day Track
S002 1984-03-06 Normal 180 Day Track
S001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.