PMA P030010S002

Device: SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S002
Product code: MUE
Decision date: 2005-06-20
Generic name: Full field digital, system, x-ray, mammographic
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.

Current openFDA PMA Record#

Device: SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S002
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2005-06-20
Decision code: APPR
Date received: 2005-05-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.