SIEMENS MAMMOMAT NOVATION FFDM SYSTEM

FDA Premarket Approval P030010 S001

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

Approval to change the acquisition workstation (aws) from the currently approved unix-based sun workstation with solaris 8 operating system to a fujitsu/siemens m420pc with syngo operating system and the proposed changes allowing the software drivers for the detector interface (drul) to be windows xp based.

DeviceSIEMENS MAMMOMAT NOVATION FFDM SYSTEM
Generic NameFull Field Digital, System, X-ray, Mammographic
ApplicantSIEMENS MEDICAL SOLUTION
Date Received2005-01-19
Decision Date2005-07-07
PMAP030010
SupplementS001
Product CodeMUE 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTION 51 Valley Stream Pkwy. malvern, PA 19355

Supplemental Filings

Supplement NumberDateSupplement Type
P030010Original Filing
S006 2009-10-13 Normal 180 Day Track
S005 2009-07-22 Normal 180 Day Track
S004 2009-05-18 Special (immediate Track)
S003 2005-10-26 Real-time Process
S002 2005-05-20 Special (immediate Track)
S001 2005-01-19 Normal 180 Day Track

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