|
Device | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. MALVERN, PA 19355 |
PMA Number | P030010 |
Supplement Number | S002 |
Date Received | 05/20/2005 |
Decision Date | 06/20/2005 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE OPERATORS MANUAL WHICH ADD OR STRENGTHEN A CONTRAINDICATION, WARNING, PRECAUTION, OR INFORMATION ABOUT AN ADVERSE REACTION AND ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. |