3Dimensions

Digital Breast Tomosynthesis

FDA Premarket Approval P080003 S004

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 for a change to the selenia dimensions name to 3dimensions.

Device3Dimensions
Classification NameDigital Breast Tomosynthesis
Generic NameDigital Breast Tomosynthesis
ApplicantHOLOGIC, INC.
Date Received2017-03-30
Decision Date2017-04-20
PMAP080003
SupplementS004
Product CodeOTE
Advisory CommitteeRadiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P080003Original Filing
S008 2019-04-04 Normal 180 Day Track
S007 2018-05-02 Real-time Process
S006 2017-09-15 Normal 180 Day Track
S005 2017-05-02 Special (immediate Track)
S004 2017-03-30 Special (immediate Track)
S003 2016-03-30 Normal 180 Day Track
S002
S001 2012-10-09 Panel Track

NIH GUDID Devices

Device IDPMASupp
15420045508033 P080003 000
15420045512696 P080003 000
15420045512474 P080003 000
15420045510388 P080003 000
15420045511897 P080003 000
15420045512313 P080003 000
15420045510395 P080003 000
15420045500013 P080003 000
15420045507272 P080003 000
15420045507289 P080003 000
15420045507296 P080003 000
15420045508019 P080003 000
15420045508026 P080003 000
15420045512689 P080003 000
15420045500020 P080003 001

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