PMA P010025S016

Device
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
Hologic, Inc.
PMA number
P010025
Supplement
S016
Product code
MUE
Decision date
2009-05-01
Generic name
Full field digital, system, x-ray, mammographic
Approval order statement
CHANGE TO THE COMPUTER HOUSING.

Current openFDA PMA Record#

Device
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
Hologic, Inc.
PMA number
P010025
Supplement
S016
Product code
MUE
Generic name
Full field digital, system, x-ray, mammographic
Decision date
2009-05-01
Decision code
OK30
Date received
2009-04-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE COMPUTER HOUSING.