GYROSCAN(TM)

FDA Premarket Approval P840063 S004

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

DeviceGYROSCAN(TM)
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
Date Received1987-04-08
Decision Date1987-07-13
PMAP840063
SupplementS004
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address PHILIPS MEDICAL SYSTEMS, INC. 710 Bridgeport Ave. p.o. Box 860 shelton, CT 06484

Supplemental Filings

Supplement NumberDateSupplement Type
P840063Original Filing
S007 1987-11-05 Normal 180 Day Track
S006 1987-11-05 Normal 180 Day Track
S005 1987-05-06 Normal 180 Day Track
S004 1987-04-08 Special (immediate Track)
S003 1986-11-07 Normal 180 Day Track
S002 1986-10-31 Normal 180 Day Track
S001 1986-10-16 Normal 180 Day Track

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