|
Device | GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | GE Healthcare 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 |
PMA Number | P990066 |
Supplement Number | S011 |
Date Received | 02/07/2002 |
Decision Date | 02/22/2002 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A SUPPLIER FOR THE GANTRY ELECTRONIC BOARDS OF THE SENOGRAPHE 2000D FFDM SYSTEM. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE. |