PMA P030010S004

Device
MAMMOMAT NOVATION DR
Applicant
Siemens Medical Solution
PMA number
P030010
Supplement
S004
Product code
MUE
Decision date
2009-06-04
Generic name
Full field digital, system, x-ray, mammographic
Approval order statement
APPROVAL FOR LABELING CHANGES.

Current openFDA PMA Record#

Device
MAMMOMAT NOVATION DR
Applicant
Siemens Medical Solution
PMA number
P030010
Supplement
S004
Product code
MUE
Generic name
Full field digital, system, x-ray, mammographic
Decision date
2009-06-04
Decision code
APPR
Date received
2009-05-18
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR LABELING CHANGES.