PMA P950039S034

Device
THINPREP PROCESSORS
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S034
Product code
MKQ
Decision date
2016-01-11
Classification
Processor, Cervical Cytology Slide, Automated
Generic name
Processor, cervical cytology slide, automated
Approval order statement
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE THINPREP 5000 PROCESSOR.

Current openFDA PMA Record#

Device
THINPREP PROCESSORS
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S034
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2016-01-11
Decision code
APPR
Date received
2015-10-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE THINPREP 5000 PROCESSOR.