PMA P950039S038

Device
ThinPrep 5000 Processor
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S038
Product code
MKQ
Decision date
2019-09-03
Classification
Processor, Cervical Cytology Slide, Automated
Generic name
Processor, cervical cytology slide, automated
Approval order statement
Approval for software upgrade to the ThinPrep 5000 processor

Current openFDA PMA Record#

Device
ThinPrep 5000 Processor
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S038
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2019-09-03
Decision code
APPR
Date received
2019-06-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software upgrade to the ThinPrep 5000 processor