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.
Device | MAGNISCAN 5000 MRI SYSTEM |
Generic Name | System, Nuclear Magnetic Resonance Imaging |
Applicant | THOMSON-CGR MEDICAL CORP. |
Date Received | 1987-08-07 |
Decision Date | 1987-12-30 |
PMA | P850043 |
Supplement | S001 |
Product Code | LNH |
Advisory Committee | Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | THOMSON-CGR MEDICAL CORP. 10150 Old Columbia Rd. columbia, MD 21046 |
Supplement Number | Date | Supplement Type |
---|---|---|
P850043 | Original Filing | |
S002 | 1987-09-01 | Normal 180 Day Track |
S001 | 1987-08-07 | Normal 180 Day Track |