Note: 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. |
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Device | MAMMOMAT NOVATION DR |
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 | S004 |
Date Received | 05/18/2009 |
Decision Date | 06/04/2009 |
Reclassified Date
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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. |
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